Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy

Phase 3

Active, not recruiting

• Conditions: Recurrent Prostate Carcinoma

• Registration Number: NCT03582774
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-07-11
• Study Start: 2018-07-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-07-12
• Study Completion: 2027-07-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 193

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (2)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

UCSF Medical Center-Mount Zion; 🇺🇸 San Francisco, California, United States