Recurrent Prostate Carcinoma
Conditions
Keywords
PSMA, PET/CT, salvage radiation therapy, randomized trial
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPositron Emission Tomography
Undergo PET/CT
OTHERBest Practice
Undergo standard of care
PROCEDUREComputed Tomography
Undergo PET/CT
RADIATIONGallium Ga 68-labeled PSMA-11
Given IV
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Histopathology proven prostate cancer. * Planned SRT for recurrence after primary prostatectomy. * Prostate-specific antigen (PSA) \>= 0.1 ng/ml at time of enrollment. * Willingness to undergo radiotherapy. * Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.
Exclusion criteria
* Extra-pelvic metastasis on any imaging or biopsy. * Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT. * Contraindications to radiotherapy (including active inflammatory bowel disease). * Concurrent systemic therapy for prostate cancer with investigational agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of salvage radiation therapy (SRT) | From date of initiation of SRT assessed up to 5 years | Will be measured as biochemical progression-free survival after initiation of SRT. Will use a log rank test to compare progression free survival time between the two randomized treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical progression-free survival rate | From date of randomization assessed up to 5 years | Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., androgen deprivation therapy \[ADT\], pelvic lymph node radiation therapy \[LN RT\], prostate specific antigen \[PSA\] doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes). |
| Metastasis free survival | Up to 5 years | Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes). |
| Initiation of additional salvage therapy after completion of SRT | Up to 5 years | Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes). |
| Change in initial treatment intent | Up to 5 years | Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes). |
Countries
United States
Outcome results
None listed