Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness (IAPSMA)
Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer
The goal of this clinical trial is to learn whether intra-arterial (IA) administration of 68Ga-PSMA improves tumor uptake and distribution compared with standard intravenous (IV) administration in patients with localized high-risk prostate cancer. The study will also evaluate the safety of the IA procedure and investigate whether advanced PET/CT imaging features can help predict the radiation dose needed for future personalized 177Lu-PSMA radioligand therapy.
The main questions it aims to answer are:
- Does intra-arterial 68Ga-PSMA administration result in higher and more homogeneous tumor uptake than standard intravenous administration?
- Can PET/CT texture analysis and dosimetric modeling predict the radiation dose required to achieve a curative effect with 177Lu-PSMA therapy?
- What radiation exposure and procedure-related risks are associated with intra-arterial administration for patients and medical staff?
Researchers will compare PSMA uptake and distribution after intravenous and intra-arterial administration of 68Ga-PSMA using PET/CT imaging.
Participants will:
- Undergo a standard intravenous 68Ga-PSMA PET/CT scan.
- Undergo a second 68Ga-PSMA PET/CT scan following selective intra-arterial administration through the prostatic artery.
- Have imaging data analyzed using advanced texture analysis and voxel-based dosimetry methods.
- Undergo radical prostatectomy according to standard clinical care, with pathological analysis of surgical specimens.
- Be monitored for adverse events, radiation exposure, and procedural safety throughout the study.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PSMA-targeted radioligands have become an important tool for imaging and treatment of prostate cancer. Intravenous (IV) administration is the current standard route of administration; however, intra-arterial (IA) delivery through the prostatic artery may increase local radioligand concentration within the tumor while reducing systemic distribution.
This prospective, single-center, interventional study aims to evaluate the effect of IA administration of 68Ga-PSMA on tracer distribution and tumor uptake in patients with localized high-risk prostate cancer undergoing radical prostatectomy.
Participants will undergo standard-of-care 68Ga-PSMA PET/CT imaging following intravenous administration and a second PET/CT examination following selective intra-arterial administration of 68Ga-PSMA through the prostatic artery. Quantitative PET/CT analysis will be used to compare tumor uptake, tumor-to-background ratios, and intratumoral distribution between the two administration routes.
The study will also establish and evaluate a standardized technique for selective prostatic artery catheterization and IA radioligand administration. Procedural feasibility, technical success, adverse events, and radiation exposure to patients and medical personnel will be assessed.
Advanced radiomic texture analysis and voxel-based dosimetry will be performed on PET/CT datasets to characterize intratumoral heterogeneity and investigate imaging biomarkers associated with radiotracer distribution. These data will be used to develop predictive models estimating the radiation dose required to achieve a curative ("radical") effect with future 177Lu-PSMA radioligand therapy.
Following imaging, participants will undergo radical prostatectomy according to standard clinical practice. Histopathological findings will be correlated with imaging-derived uptake and texture parameters.
The study is designed to determine whether IA administration improves PSMA uptake and distribution compared with IV administration and to explore imaging-based approaches for personalized radioligand therapy planning in localized prostate cancer.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Donatas Vajauskas, Professor
- 전화번호: +37068750906
- 이메일: donatas.vajauskas@lsmu.lt
연구 연락처 백업
- 이름: Rūta Dubeikaitė
- 전화번호: +37062266019
- 이메일: ruta.dubeikaite@lsmu.lt
연구 장소
-
-
-
Kaunas, 리투아니아, LT-50103
- Lithuanian University of Health Sciences Kaunas Clinics
-
연락하다:
- Administrator
- 전화번호: +3703770337
- 이메일: rastine@kaunoklinikos.lt
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult male patients with biopsy-proven prostate adenocarcinoma up to stages ≤T3bN1 by initial preoperative examination, with no distant metastases (M0) on ⁶⁸Ga-PSMA PET/CT.
- Systemic therapy-naive patients scheduled for radical prostatectomy with/without pelvic lymph node dissection with curative intent.
High-risk localized or locally-advanced prostate cancer according to European Association of Urology criteria, including one of the following:
- Prostate-specific antigen > 20ng/mL2 or ISUP grade 4/5.
- Clinical T stage cT3-4* and/or N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries), any ISUP grade, and any
- High PSMA avidity on ⁶⁸Ga-PSMA PET/CT, defined as SUVmax ≥20.
- Normal baseline hematological function.
- Normal serum biochemistry.
- Signed informed consent form.
Exclusion Criteria:
- Patients with other (non-adenocarcinoma) biopsy-proven histology of prostate cancer.
Patients with low-risk prostate cancer according to European Association of Urology criteria, including any of the following:
- Prostate-specific antigen <10 ng/ml.
- International Society of Urological Pathology grade group 1.
- Clinical T stage T1-T2a digital rectal examination.
- Prior radiotherapy or systemic therapy for prostate cancer.
- Prostate cancer with low PSMA avidity (SUVmax <20) on ⁶⁸Ga-PSMA PET/CT.
- Evidence of distant metastatic spread (M1) on ⁶⁸Ga-PSMA PET/CT.
- Contraindications for radical prostatectomy.
- Major comorbidities and laboratory abnormalities that might confound the results of the trial or interfere with the patient's ability to participate.
- Refusal to participate in the trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: IA-PSMA
All enrolled participants receive the same sequence of interventions:
|
Additional intervention to the standard of care for prostate cancer treatment - prostate artery catheterization and intra-arterial injection of 68Ga-PSMA with subsequent PET/CT scan.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
기간: Up to 6 weeks from enrollment.
|
To determine whether selective intra-arterial (IA) administration of ⁶⁸Ga-PSMA results in superior tumor targeting compared with standard intravenous (IV) administration.
Uptake will be quantified using PET/CT-derived parameters, including SUVmax, SUVmean, tumor-to-background ratio (TBR), and volumetric uptake metrics obtained from paired IV and IA scans performed in the same patient.
|
Up to 6 weeks from enrollment.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Technical success rate of selective intra-arterial prostate artery catheterization
기간: Up to 6 weeks from enrollment.
|
To evaluate the feasibility and reproducibility of the developed IA delivery protocol by assessing successful selective catheterization of the target prostatic artery and completion of radiotracer administration according to protocol.
|
Up to 6 weeks from enrollment.
|
|
Procedural safety of intra-arterial PSMA administration
기간: From IA administration until radical prostatectomy at up to 3 months from enrollment.
|
To assess the safety profile of IA radioligand administration, including procedure-related complications and adverse events.
Number, type, and severity of adverse events graded according to CTCAE v5.0; incidence of vascular complications, non-target administration, bleeding, infection, or other procedure-related events
|
From IA administration until radical prostatectomy at up to 3 months from enrollment.
|
|
Patient and operator radiation exposure during intra-arterial versus intravenous procedures
기간: Up to 6 weeks from enrollment.
|
To compare the radiation burden associated with IA and IV administration pathways.
Absorbed radiation dose (mSv) derived from measurement during and after the procedure.
|
Up to 6 weeks from enrollment.
|
|
Identification of PET texture biomarkers associated with optimal tumor saturation
기간: Up to 1 year from enrollment.
|
To identify radiomic features predictive of favorable intratumoral radiotracer distribution and complete lesion saturation.
Association between extracted texture features and dosimetric endpoints using regression and machine-learning analyses.
|
Up to 1 year from enrollment.
|
|
Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy
기간: Up to 1 year from enrollment.
|
To estimate the radiation dose that would be delivered to tumor tissue during therapeutic ¹⁷⁷Lu-PSMA administration based on diagnostic PET-derived biodistribution.
Voxel-based absorbed dose estimates (Gy) and dose-volume histogram parameters.
|
Up to 1 year from enrollment.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PSMA 1.0
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
전립선암에 대한 임상 시험
-
NCT03987217완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8
-
NCT01799278완전한신경내분비성 전립선암 | 소세포 전립선암 | Prostate Adenocarcinoma Plus > 신경내분비 표지자에 대한 50% 면역조직화학적 염색
-
NCT06216249모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8
-
NCT07468903모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8
-
NCT04399824빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8
-
NCT04624256모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8
-
NCT06870396초대로 등록부신 종양 | 페로 크로 모세포종 및 paraganglioma (PPGL) | Adrenocorticol Cancer (ACC)
-
NCT05398302모병거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8
Intraarterial injection of 68Ga-PSMA에 대한 임상 시험
-
NCT07310355아직 모집하지 않음전이성 거세 저항성 전립선암(mCRPC)