Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jeremie Calais (ucla)

Description

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).

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. 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.

Keywords

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 PSMA PET/CT randomized trial definitive Radiation Therapy prostate cancer Prostatic Neoplasms Fluorides Computed Tomography Fluorine F 18 DCFPyL Positron Emission Tomography Radiation Therapy

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT04457245
Phase
Phase 3
Study Type
Interventional
Last Updated