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진행성 전이성 거세 저항성 전립선암 치료에서 177Lu-PSMA-617 대 안드로겐 수용체 지시 요법 (PSMAfore)

2026년 10월 9일 업데이트: Novartis Pharmaceuticals

PSMAfore: 진행성 전이성 거세 저항성 전립선암을 앓고 있는 탁산 무경험 남성의 치료에서 177Lu-PSMA-617과 안드로겐 수용체 지시 요법의 변화를 비교하는 III상, 공개 라벨, 다기관, 무작위 연구

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.

469 participants were randomized (235 in the 177Lu-PSMA-617 group and 234 in the ARDT group.

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
완전한

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

상세 설명

This is a phase III, open label, multicenter randomized study evaluating the superiority of 177Lu-PSMA-617 over a change of ARDT treatment in prolonging rPFS. The primary endpoint of rPFS is to assess via blinded independent centralized review (BICR) of radiographic images provided by the treating physician and as outlined in PCWG3 modified RECIST v 1.1 Guidelines.

The study also evaluates whether 177Lu-PSMA-617 improves the overall survival (OS) in participants with progressive PSMA-positive mCRPC compared to participants treated with a change in ARDT treatment. OS is defined as the time from randomization to death due to any cause.

Treatment duration: approximately 43 months.

Screening period At screening, the participants are assessed for eligibility and undergo a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria are randomized.

Randomization period The participants are randomized 1:1 to receive 177Lu-PSMA-617 or a change of the ARDT treatment. The ARDT change includes approved Androgen Receptor (AR) axis targeted therapy (abiraterone or enzalutamide). Supportive care is allowed in both arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT). Investigational agents, biological products, immunotherapy, cytotoxic chemotherapy, other systemic radioisotopes (e.g. radium-223), poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors or hemi-body radiotherapy treatment is not to be administered during the study treatment period. ARDT is not to be administered concomitantly with 177Lu-PSMA-617. After implementation of Protocol Amendment v4, crossover will be allowed regardless of radiographic progression.

Treatment period • 177Lu-PSMA-617 treatment arm Participants randomized to the investigational arm receive 7.4 GBq +/- 10% of 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT, could be used.

After the last day of study treatment, the participants have to have an End of Treatment (EOT) visit and enter the Post-treatment Follow-up.

• ARDT treatment arm For participants randomized to the ARDT treatment arm, the change of ARDT treatment for each participant is selected by the treating physician prior to randomization and is administered per the physician's orders. Best supportive care, including ADT, could be used. After, the participants have to have an End of Treatment (EOT) and enter the Post-treatment Follow-up.

In absence of safety concerns, every effort should be made to keep the participant on the randomized treatment until BICR-determined radiographic progression (up to implementation of Protocol Amendment v4).

End of Treatment

Randomized treatment may be discontinued if:

  • The participant, sponsor or investigator chooses to discontinue treatment
  • Toxicity
  • Completion of the 6 cycles of 177Lu-PSMA-617
  • Serious non-compliance to the protocol
  • Disease progression (determined by BICR up to implementation of Protocol Amendment v4)
  • Upon implementation of Protocol Amendment v4, participants with ongoing treatment with ARDT will discontinue study drug and either crossover or receive SOC per their treating physician off trial PSA progression is strongly discouraged as a criterion for initiation of a new neoplastic therapy prior to BICR-determined progression. PCWG3 guidelines should be followed to guide discontinuation of treatment End of Treatment visit must be performed ≤ 7 days after the last day of study treatment period. EOT is to occur before the participant enters the post-treatment Follow-up period of the study and before the initiation of any subsequent anticancer treatment, .

If a participant withdraws consent for the treatment period of the study, an EOT must be done and the participant will enter the Post-treatment Follow-up unless he specifically withdraws post-treatment Follow-up.

Crossover period Upon confirmation of rPFS by BICR, participants randomized to the ARDT arm could either be allowed to crossover to receive 177Lu-PSMA-617 within 28 days of central confirmation of radiographic progression or could continue to receive any other therapy per the discretion of the treating physician in the Post-treatment Follow-up.

In order for a participant randomized to the ARDT arm to cross over to receive 177Lu-PSMA-617, he must meet the following criteria:

  • Confirmed radiographical progression as assessed by BICR. (After implementation of Protocol Amendment v4, radiographic progression is not required.)
  • No intervening antineoplastic therapy is administered after the randomized treatment
  • Any unresolved toxicity from prior therapy has to be controlled and can be no greater than CTCAE grade 2 or baseline at the time of registration for crossover.
  • ECOG performance status 0-1 at the time of registration for crossover
  • Adequate organ function at the time of registration for crossover
  • Agreement to continue with the study visit schedule

A participant, who is deemed to have disease progression per investigator assessment, but not by BICR, is not eligible to cross over at that time. Such participant should continue to receive randomized study treatment until progression determined by BICR up to implementation of Protocol Amendment v4.

If crossover to 177Lu-PSMA-617 is selected, then 177Lu-PSMA-617 will be administered with the same dose/schedule as for participants who were initially randomized to receive 177Lu-PSMA-617 as described above.

After the last day of study treatment period of 177Lu-PSMA-617 or upon second radiographic progression (rPFS2), the participants must have a second End of Treatment (EOT2) visit performed ≤ 7 days and enter the Post-treatment Follow-up. The participant can receive any other therapy per the discretion of the treating physician in the Post-treatment Follow-up.

Post-treatment Follow-up period:

  • 30-day Safety Follow-up: All randomized and/or treated participants are to have a safety follow-up conducted approximately 30 days after the EOT visit.
  • Long term follow-up:

Long term follow-up starts after the 30 Days Safety follow-up and lasts until the patient expires, is lost to follow-up or withdraws consent.

In long term follow-up safety and efficacy information is collected:

  • Safety: all medically significant adverse events (all SAEs) deemed to be related to 177Lu-PSMA-617. This includes potential late onset radiation toxicity. For participants who receive 177Lu-PSMA-617 in the 177Lu-PSMA-617 arm or in crossover, the following adverse events is captured beyond the 30 day safety period regardless of relationship to study treatment and whether new anticancer therapy has been initiated: hematologic toxicities with primary focus on myelosuppression and thrombocytopenia (including need for transfusion or use of growth factors), renal failure, xerostomia, xerophthalmia, secondary malignancies. After implementation of Protocol Amendment v4, 177Lu-PSMA-617 exposed participants will be discontinued from the trial once enrolled in the Long-term Safety study.
  • Efficacy: Tumor assessments must be performed every 8 weeks after first dose of study treatment for the first 24 weeks (week 9, 17, 25) and then every 12 weeks (week 37, 49, etc.) until confirmation of radiographic progression by BICR regardless of whether treatment has been discontinued or new anticancer therapy initiated. After implementation of Protocol Amendment v4, tumor assessments need to continue only for patients actively treated with 177Lu-PSMA-617 as crossover therapy.

The long-term follow-up period also includes the collection of survival information and other assessments.

Other: Other data collected during long-term follow-up includes short physical exam, blood sampling for hematology, chemistry testing, coagulation, DNA and tumor samples for biomarkers. The visits are carried out every 12 weeks (± 28 days) .

Participants who receive 177Lu-PSMA-617 and remain in follow-up on the trial at the sponsor's completion of the study will be asked to join a separate study of long-term safety for a duration of up to 10 years from start of 177Lu-PSMA-617 treatment.

If the participant withdraws consent for the collection of blood samples, PROs, and imaging assessments during the long-term follow-up, information on survival subsequent therapy, and related SAEs is collected.

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (실제)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
469

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 네덜란드
      • Nijmegen, 네덜란드, 6525 GA
        • Novartis Investigative Site
      • Utrecht, 네덜란드, 3584 CX
        • Novartis Investigative Site
    • Limburg
      • Maastricht, Limburg, 네덜란드, 6229 HX
        • Novartis Investigative Site
  • 독일
      • Essen, 독일, 45147
        • Novartis Investigative Site
      • München, 독일, 80377
        • Novartis Investigative Site
  • 미국
    • Colorado
      • Denver, Colorado, 미국, 80218
        • Rocky Mountain Cancer Centers
    • Florida
      • Gainesville, Florida, 미국, 32610
        • University of Florida
    • Louisiana
      • New Orleans, Louisiana, 미국, 70112
        • Tulane Uni Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, 미국, 02215
        • Beth Israel Deaconess Med Ctr
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • WA Uni School Of Med
    • Nebraska
      • Omaha, Nebraska, 미국, 68130
        • Urology Cancer Center PC
      • Omaha, Nebraska, 미국, 68154
        • Nebraska Cancer Specialists
    • New York
      • New York, New York, 미국, 10016
        • NYU Laura and Isaac Perlmutter Cancer Center
      • New York, New York, 미국, 10065
        • Memorial Sloan Kettering Cancer Ctr
      • New York, New York, 미국, 10029
        • Mount Sinai Hosp Med School
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke Univ Medical Center
    • Ohio
      • Columbus, Ohio, 미국, 43221
        • The Ohio State University Comprehensive Cancer Center
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • Tennessee Oncology
    • Texas
      • Houston, Texas, 미국, 77030
        • Uni Of TX MD Anderson Cancer Cntr
    • Utah
      • Salt Lake City, Utah, 미국, 84106
        • Utah Cancer Specialists
    • Virginia
      • Norfolk, Virginia, 미국, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, 미국, 24014
        • Onco Hemato Asso of SW Virginia
    • Washington
      • Seattle, Washington, 미국, 98109
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • Medical College Of Wisconsin
  • 벨기에
      • Brussels, 벨기에, 1200
        • Novartis Investigative Site
      • Ghent, 벨기에, 9000
        • Novartis Investigative Site
      • Liège, 벨기에, 4000
        • Novartis Investigative Site
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, 벨기에, 8800
        • Novartis Investigative Site
  • 스웨덴
      • Gothenburg, 스웨덴, 413 45
        • Novartis Investigative Site
      • Lund, 스웨덴, 221 85
        • Novartis Investigative Site
      • Stockholm, 스웨덴, 17176
        • Novartis Investigative Site
  • 스위스
      • Baden, 스위스, 5404
        • Novartis Investigative Site
      • Lausanne, 스위스, 1011
        • Novartis Investigative Site
      • Zurich, 스위스, 8091
        • Novartis Investigative Site
  • 스페인
      • Barcelona, 스페인, 08035
        • Novartis Investigative Site
      • Barcelona, 스페인, 08036
        • Novartis Investigative Site
      • Barcelona, 스페인, 08041
        • Novartis Investigative Site
      • Madrid, 스페인, 28041
        • Novartis Investigative Site
      • Madrid, 스페인, 28040
        • Novartis Investigative Site
      • Madrid, 스페인, 28009
        • Novartis Investigative Site
      • Madrid, 스페인, 28222
        • Novartis Investigative Site
      • Málaga, 스페인, 29010
        • Novartis Investigative Site
      • Seville, 스페인, 41013
        • Novartis Investigative Site
      • Valencia, 스페인, 46026
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, 스페인, 15706
        • Novartis Investigative Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, 스페인, 08907
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, 스페인, 30120
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, 스페인, 31008
        • Novartis Investigative Site
    • Valencia
      • Valencia, Valencia, 스페인, 46009
        • Novartis Investigative Site
  • 슬로바키아
      • Bratislava, 슬로바키아, 83310
        • Novartis Investigative Site
  • 영국
      • Coventry, 영국, CV2 2DX
        • Novartis Investigative Site
      • London, 영국, NW3 2QG
        • Novartis Investigative Site
      • London, 영국, EC1A 7BE
        • Novartis Investigative Site
      • London, 영국, NW1 2BU
        • Novartis Investigative Site
      • Middlesbrough, 영국, TS4 3BW
        • Novartis Investigative Site
    • Surrey
      • Guildford, Surrey, 영국, GU2 7XX
        • Novartis Investigative Site
      • Sutton, Surrey, 영국, SM2 5PT
        • Novartis Investigative Site
  • 오스트리아
      • Linz, 오스트리아, 4020
        • Novartis Investigative Site
      • Vienna, 오스트리아, 1090
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, 오스트리아, 6020
        • Novartis Investigative Site
  • 체코
      • Olomouc, 체코, 779 00
        • Novartis Investigative Site
  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V5Z 4E6
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, 캐나다, H3T 1E2
        • Novartis Investigative Site
      • Montreal, Quebec, 캐나다, H2X 1R9
        • Novartis Investigative Site
  • 폴란드
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, 폴란드, 44-101
        • Novartis Investigative Site
  • 프랑스
      • Angers, 프랑스, 49055
        • Novartis Investigative Site
      • Bordeaux, 프랑스, 33076
        • Novartis Investigative Site
      • Clermont-Ferrand, 프랑스, 63011
        • Novartis Investigative Site
      • Lyon, 프랑스, 69373
        • Novartis Investigative Site
      • Paris, 프랑스, 75970
        • Novartis Investigative Site
      • Villejuif, 프랑스, 94800
        • Novartis Investigative Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.

  • Participants must be adults >= 18 years of age.

  • Participants must have an ECOG performance status of 0 to 1.

  • Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate.

  • Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader.

  • Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).

  • Participants must have progressed only once on prior second generation ARDT (abiraterone, enzalutamide, darolutamide, or apalutamide).

    • First generation androgen receptor inhibitor therapy (e.g. bicalutamide) is allowed but not considered as prior ARDT therapy.
    • Second generation ARDT must be the most recent therapy received.

  • Participants must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:

    • Serum/plasma PSA progression defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression.
    • Soft-tissue progression defined [PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)].
    • Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016)).

  • Participants must have >= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained prior to randomization.

  • Participants must have recovered to =< Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, etc.) except alopecia.

  • 11. Participants must have adequate organ function:

    • Bone marrow reserve:
    • ANC >= 1.5 x 109/L
    • Platelets >= 100 x 109/L
    • Hemoglobin >= 9 g/dL
    • Hepatic:
    • Total bilirubin < 2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =< 3 x ULN is permitted.
    • ALT or AST =< 3.0 x ULN OR =< 5.0 x ULN for participants with liver metastases.
    • Renal:
    • eGFR >= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation.

  • Albumin >= 2.5 g/dL. -. Candidates for change in ARDT as assessed by the treating physician: • Participants cannot have previously progressed nor had intolerable toxicity to both enzalutamide and abiraterone.

Exclusion Criteria:

  • Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.

  • Previous PSMA-targeted radioligand therapy.

  • Prior treatment with cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed].

  • Any investigational agents within 28 days prior to day of randomization.

  • Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar classes.

    -. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.

  • Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for study inclusion.

  • Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.

  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.

  • History or current diagnosis of the following ECG abnormalities indicating significant risk of safety for study participants:

    • Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block).
    • History of familial long QT syndrome or known family history of Torsades de Pointe.
    • Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or CABG within 6 months prior to starting study treatment.

  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.

    • HIV-infected participants who are at a low risk of AIDS-related outcomes may participate in this trial.
    • Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance).

  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free and treatment free for more than 3 years prior to randomization, are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.

  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner.

In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.

  • Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: Participant with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed.
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Any condition that precludes raised arms position.
  • Eligible for treatment(s) other than ARDT based on presence of any mutations or biomarkers that are known as predictors of better response (e.g., AR-V7 or BRCA).
  • Not able to understand and to comply with study instructions and requirements.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: 177Lu-PSMA-617

Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
의약품: 177Lu-PSMA-617

administered intravenously once every 6 weeks (1 cycle) for 6 cycles

의약품: 68Ga-PSMA-11

single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi).
활성 비교기: Androgen receptor-directed therapy (ARDT)

For participants randomized to the ARDT arm, abiraterone or enzalutamide was administered per the physician's orders. Best supportive care, including Androgen deprivation therapy (ADT) could be used.
의약품: 68Ga-PSMA-11

single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi).

의약품: ARDT

administered orally on a continuous basis, as per package insert and guidelines

다른 이름들:
  • 비교기

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Radiographic Progression Free Survival (rPFS)
기간: median FU (randomization to event or censoring) 3.65 months (range 0-12.3)

rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
median FU (randomization to event or censoring) 3.65 months (range 0-12.3)

2차 결과 측정

2차 결과 측정

임상 연구 프로토콜에서 개입의 효과를 평가하기 위한 1차 결과 측정만큼 중요하지는 않지만 여전히 관심이 있는 계획된 결과 측정입니다. 대부분의 임상 연구에는 하나 이상의 2차 결과 측정이 있습니다.
결과 측정
측정값 설명
기간
Overall Survival (OS) (Key Secondary Endpoint)
기간: approx. 26.9 months from randomization to cut-off

OS is defined as time to death for any cause.
approx. 26.9 months from randomization to cut-off
Radiographic Progression Free Survival 2 (rPFS2) by Blinded Independent Central Review (BICR)
기간: From date of crossover until second radiographic progression or death, whichever comes first, assessed up to approx. 32 months

rPFS2 by BICR is defined as time from the date of crossover (ARDT to 177Lu-PSMA-617) to the date of radiographic disease progression by BICR or death from any cause for participants who crossover from ARDT arm to Lu-PSMA treatment.
From date of crossover until second radiographic progression or death, whichever comes first, assessed up to approx. 32 months
Progression Free Survival (PFS) by Investigator's Assessment
기간: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed upFrom date of randomization until date of death from any cause, assessed up to approx. 32 months

PFS is defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic, clinical, or PSA progression) or death from any cause, whichever occurs first
From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed upFrom date of randomization until date of death from any cause, assessed up to approx. 32 months
Second Progression Free Survival (PFS2) by Investigator's Assessment
기간: From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months

PFS2 defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first, on next-line of therapy. Next-line therapy was defined as the first new (systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EoT) reason.
From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months
PSA50 Response
기간: Weeks 12, 24, 48 and anytime during randomized phase

PSA50 response was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second Prostate specific antigen (PSA) measurement ≥ 4 weeks.
Weeks 12, 24, 48 and anytime during randomized phase
Time to First Symptomatic Skeletal Event (TTSE)
기간: From date of randomization till EOT or death, whichever happens first, assessed up to approx. 32 months

Time to SSE (TTSSE) defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first
From date of randomization till EOT or death, whichever happens first, assessed up to approx. 32 months
Time to Radiographic Soft Tissue Progression (TTSTP) Per BICR
기간: From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months

TTSTP defined as time from randomization to radiographic soft tissue progression per Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 (Soft Tissue Rules of Prostate Cancer Working Group modified Response Evaluation Criteria in Solid Tumors Version 1.1) as assessed by Blinded Independent Central Review (BICR).
From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months
Time to Chemotherapy (TTCT)
기간: From date of randomization until date of subsequent chemotherapy or date of death from any cause, whichever comes first, assessed up to 43 months (estimated final OS analysis)

TTCT defined as time from randomization to initiation of the first subsequent chemotherapy or death, whichever occurs first. Since participants in ARPI arm were allowed to crossover to [177Lu]Lu-PSMA-617 (AAA617) arm upon confirmation of rPD by BICR, TTCT was delayed for participants who had crossed over.
From date of randomization until date of subsequent chemotherapy or date of death from any cause, whichever comes first, assessed up to 43 months (estimated final OS analysis)
European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D- 5L)
기간: From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
기간: From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months

The FACT-P total score determines the level of prostate cancer specific health related quality of life (HRQoL). The higher the FACT-P score, the better the QoL. FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months
Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
기간: From screening up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months (estimated final OS analysis)

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.
From screening up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months (estimated final OS analysis)
Number of Participants With Treatment Emergent Adverse Events
기간: From randomization till 30 day safety follow-up, assessed up to 43 months (estimated final OS analysis).

The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Treatment emergent adverse events falling into the category of myelosuppression, renal toxicity or second malignancy will be recorded beyond 30 day safety observation period.
From randomization till 30 day safety follow-up, assessed up to 43 months (estimated final OS analysis).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
Novartis Pharmaceuticals

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2021년 6월 15일

기본 완료 (실제)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2022년 10월 2일

연구 완료 (실제)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2026년 9월 9일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2020년 12월 9일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2020년 12월 26일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2020년 12월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 10월 9일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • CAAA617B12302
  • 2023-507772-50-00 (기타 식별자: EU CTIS)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

쿠키 설정

당사는 당사 웹 사이트에서 최상의 경험을 제공하기 위해 쿠키를 사용합니다. 자세한 내용은 개인 정보 보호 및 쿠키 정책 을주의 깊게 읽어보십시오. ...>>>귀하는 정책에 설명 된대로 귀하의 웹 사이트 또는 컴퓨터에서 쿠키를 삭제하여 언제든지 귀하의 기본 설정을 변경하거나 동의를 철회 할 수 있습니다. 동의하고 아래 "설정 관리"섹션에서 해당 상자를 선택하여 기본 설정을 선택하십시오. 이 웹 사이트의 일부를 사용하기 전에 서비스 약관 을주의 깊게 읽어 보시기 바랍니다.
«설정 관리