NCT04457245

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

Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT]

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
• Stage II Prostate Cancer AJCC v8
• Stage IIA Prostate Cancer AJCC v8
• Stage IIB Prostate Cancer AJCC v8
• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo whole body PET/CT
OTHER	Fluorine F 18 DCFPyL	Given IV
PROCEDURE	Positron Emission Tomography	Undergo whole body PET/CT
RADIATION	Radiation Therapy	Undergo standard of care definitive radiation therapy

Timeline

• Start date: 2020-08-14
• Primary completion: 2023-01-10
• Completion: 2023-01-10
• First posted: 2020-07-07
• Last updated: 2023-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study