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

Phase 3

Active, not recruiting

• Conditions: Recurrent Prostate Carcinoma
• Interventions: Procedure: Computed Tomography; Other: Best Practice; Radiation: Gallium Ga 68-labeled PSMA-11; Procedure: Positron Emission Tomography

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-03
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-07-12
• Study Completion: 2026-07-12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (68Ga-PSMA-11 PET/CT)	Computed Tomography	Participants receive 68Ga-PSMA-11 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.
Arm I (standard of care)	Best Practice	Participants receive standard of care SRT.
Arm II (68Ga-PSMA-11 PET/CT)	Positron Emission Tomography	Participants receive 68Ga-PSMA-11 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.
Arm II (68Ga-PSMA-11 PET/CT)	Gallium Ga 68-labeled PSMA-11	Participants receive 68Ga-PSMA-11 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.

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)

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

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