전립선암 능동 감시 중 ProstAtak® 면역 요법의 무작위 통제 시험(ULYSSES)
새로 진단된 전립선암에 대한 활성 감시 중에 투여된 AdV-tk + Valacyclovir의 무작위 대조 시험
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Mexico City, 멕시코
- Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
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Colorado
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Golden, Colorado, 미국, 80401
- Foothills Urology
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Illinois
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Chicago, Illinois, 미국, 60637
- The University of Chicago
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Chicago, Illinois, 미국, 60612
- Jesse Brown VA Medical Center
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Louisiana
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New Orleans, Louisiana, 미국, 70119
- Southeast Louisiana Veterans Health Care System
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Maryland
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Bethesda, Maryland, 미국, 20889
- Walter Reed National Military Medical Center
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Missouri
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Kansas City, Missouri, 미국, 64128
- Kansas City VA Medical Center
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Nevada
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Reno, Nevada, 미국, 89502
- Sierra Nevada Health Care System VA
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center
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New York
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North Hills, New York, 미국, 11042
- Advanced Radiation Centers of New York (Integrated Medical Professionals)
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Syracuse, New York, 미국, 13210
- Associated Medical Professionals of NY, PLLC
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Ohio
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Middleburg Heights, Ohio, 미국, 44130
- Southwest Urology, Clinical Research Solutions
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma City VA Healthcare System
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Oregon
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Portland, Oregon, 미국, 97239
- VA Portland Health Care System
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Springfield, Oregon, 미국, 97477
- Oregon Urology Insitute
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Pennsylvania
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Lancaster, Pennsylvania, 미국, 17604
- Lancaster Urology
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Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny Health Network-Triangle Urological Group
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South Carolina
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Charleston, South Carolina, 미국, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Texas
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San Antonio, Texas, 미국, 78229-4404
- San Antonio VA Healthcare System
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The Woodlands, Texas, 미국, 77384
- Woodland Center
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Tomball, Texas, 미국, 77375
- Texas Urology Specialists
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Virginia
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Richmond, Virginia, 미국, 23249
- Hunter Holmes McGuire VA Medical Center
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Salem, Virginia, 미국, 24153
- Salem VA Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria include:
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Histologically confirmed adenocarcinoma of the prostate
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Patients choosing active surveillance
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Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
- NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
- NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
- High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
- Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
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Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
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ECOG Performance status 0-2
Exclusion Criteria include:
- Active liver disease, including known cirrhosis or active hepatitis
- Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ patients
- Regional lymph node involvement or distant metastases
- Other current malignancy (except squamous or basal cell skin cancers)
- Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
- Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
- Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
- Patients who had or plan to use ADT or have history of an orchiectomy.
- Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
- Known sensitivity or allergic reactions to acyclovir or valacyclovir
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
다른 이름들:
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. |
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위약 비교기: Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir |
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-free survival (PFS)
기간: Baseline to study completion, approximately 5 years
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Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer |
Baseline to study completion, approximately 5 years
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2차 결과 측정
결과 측정 |
기간 |
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1년 랜드마크에서 음성 생검율
기간: 일년
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일년
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부작용이 있는 환자의 비율
기간: 연구 약물의 마지막 투여 후 30일
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연구 약물의 마지막 투여 후 30일
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PrTK04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .