Recurrent Prostate Carcinoma Clinical Trial
Official title:
Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET/CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.
PRIMARY OBJECTIVE: I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT. SECONDARY OBJECTIVES: I. Sub-group analysis of the primary endpoint (success rate of SRT) within the subgroup with baseline PSA ≥ 0.5 ng/ml II. 5-year biochemical progression-free survival rate (from date of randomization). III. Metastasis free survival. IV. Initiation of additional salvage therapy after completion of SRT. V. Change in initial treatment intent. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive standard of care SRT. ARM II: Participants receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist. After conclusion of PET/CT, participants are followed up periodically for up to 5 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04457232 -
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
|
Phase 1 | |
| Active, not recruiting |
NCT03796767 -
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
|
Phase 2 | |
| Withdrawn |
NCT05034562 -
Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00936975 -
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
|
Phase 2 | |
| Active, not recruiting |
NCT00486642 -
Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
|
Phase 2 | |
| Completed |
NCT02940262 -
Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
|
Phase 3 | |
| Completed |
NCT01787331 -
Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02807805 -
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
|
Phase 2 | |
| Completed |
NCT01026623 -
Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT00536991 -
Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02522715 -
Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Terminated |
NCT02985021 -
Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies
|
Phase 2 | |
| Active, not recruiting |
NCT02312557 -
Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide
|
Phase 2 | |
| Active, not recruiting |
NCT01953640 -
Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy
|
||
| Completed |
NCT02673151 -
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
|
Phase 2/Phase 3 | |
| Completed |
NCT00064129 -
Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
|
Phase 1 | |
| Recruiting |
NCT04519879 -
White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA
|
Phase 2 | |
| Recruiting |
NCT03016741 -
Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer
|
Phase 4 | |
| Completed |
NCT01576172 -
Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 |