Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer

Phase 3TerminatedNCT04457245

Jonsson Comprehensive Cancer Center54 enrolled

Overview

This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT).

PRIMARY OBJECTIVE: I. To compare the outcome of patients with unfavorable intermediate (IR) and high-risk (HR) prostate cancer (PCa) after standard dRT versus prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-based dRT. OUTLINE: Patients are randomized to 1 of 2 arms. In both arms, no other primary treatment should be given before RT. Arm I: Patients do not undergo PSMA PET for dRT planning. Patients undergo standard of care dRT at the discretion of the treating radiation oncologist. Arm II: Patients undergo PSMA PET for dRT planning. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives the PSMA PET result and images. After completion of dRT, clinical follow-up of patients with their treating radiation oncologist will be obtained for 5 years. The investigators will rely on the medical records obtained from the treating physicians as the primary source of outcome data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male 18 years or older * Histopathologically-proven PCa * Unfavorable IR to HR disease: * Prostate specific antigen (PSA) \>= 10 ng/mL * Or cT-stage \>= 2b * Or Gleason grade 3 (4+3=7) or higher * Or Gleason grade 2 (3+4=7) AND \>= 50% positive biopsy cores * Or Decipher Score \>= 0.45 * Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (intervention arm 2) * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Less than 18 years old at the time of investigational product administration * Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done before randomization * Prior PSMA PET * Prior pelvic RT * Contraindications to radiotherapy (including active inflammatory bowel disease) * Concurrent or prior surgery or systemic therapy for PCa at the time of randomization

Outcomes

Primary Outcomes

Success rate of definitive radiation therapy (dRT)

Will be measured as progression-free survival after initiation of dRT. Progression is defined as (whichever occurs first): A biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir prostate specific antigen (PSA) (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy, appearance of metastasis or loco-regional recurrence (diagnosed by any imaging or biopsy), initiation of any new salvage therapy or death from any cause. Survival curves will be constructed using the Kaplan-Meier method.

Time frame: From date of randomization to first occurrence of progression, assessed up to 5 years

Secondary Outcomes

Loco-regional progression free survival

Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.