Clinical Trials /

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

NCT04457245

Description:

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).

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04457245

Trial Eligibility

Document

Title

  • Brief Title: Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer
  • 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]

Clinical Trial IDs

  • ORG STUDY ID: 20-000378
  • SECONDARY ID: NCI-2020-03445
  • NCT ID: NCT04457245

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

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm I (dRT)Active Comparator150 Patients undergo standard dRT at the discretion of the treating radiation oncologist. Patient does not undergo PSMA PET for RT planning. Any other imaging is allowed, including CT/BS/MR/PET depending on local practice. No other primary treatment can be given before dRT. If a patient assigned to the control arm undergo a PSMA PET scan at another institution he will be discontinued from the study.
    Arm II (18F-DCFPyL, PET/CT, dRT)Experimental162 Patient undergoes PSMA PET with 18F-DCFPyL for dRT planning. Any other imaging is allowed, including CT/BS/MR/PET depending on local practice. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives PSMA PET results and images. No other primary treatment can be given before RT.

      Eligibility Criteria

              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
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Success rate of definitive radiation therapy (dRT)
      Time Frame:From date of randomization to first occurrence of progression, assessed up to 5 years
      Safety Issue:
      Description: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.

      Secondary Outcome Measures

      Measure:Loco-regional progression free survival
      Time Frame:Up to 5 years after the date of randomization
      Safety Issue:
      Description:Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.
      Measure:Metastasis-free survival after initiation of radiation therapy (RT)
      Time Frame:Up to 5 years after the date of randomization
      Safety Issue:
      Description:Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.
      Measure:Overall survival
      Time Frame:Up to 5 years after the date of randomization
      Safety Issue:
      Description:
      Measure:Change in initial treatment intent
      Time Frame:Baseline up to 5 years after the date of randomization
      Safety Issue:
      Description:Will estimate the proportion of subjects in the prostate-specific membrane antigen (PSMA) group that have a change in the initial treatment intent and compute a 95% confidence interval for that proportion.
      Measure:PSMA positron emission tomography (PET) derived predictors of progression-free survival
      Time Frame:Up to 5 years after the date of randomization
      Safety Issue:
      Description:Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival.
      Measure:PSMA PET derived predictors of overall survival
      Time Frame:Up to 5 years after the date of randomization
      Safety Issue:
      Description:Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Jonsson Comprehensive Cancer Center

      Trial Keywords

      • PSMA
      • PET/CT
      • randomized trial
      • definitive Radiation Therapy
      • prostate cancer

      Last Updated

      July 22, 2021