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

Phase 3

Terminated

• Conditions: Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage II Prostate Cancer AJCC v8; Stage IIIC 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 IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8
• Interventions: Procedure: Computed Tomography; Other: Fluorine F 18 DCFPyL; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy

• Registration Number: NCT04457245
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2020-08-14
• Status Verified: 2023-01
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-10
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (18F-DCFPyL, PET/CT, dRT)	Radiation Therapy	162 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.
Arm II (18F-DCFPyL, PET/CT, dRT)	Positron Emission Tomography	162 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.
Arm II (18F-DCFPyL, PET/CT, dRT)	Fluorine F 18 DCFPyL	162 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.
Arm I (dRT)	Radiation Therapy	150 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)	Computed Tomography	162 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.

Primary Outcome Measures

Name	Time	Method
Success rate of definitive radiation therapy (dRT)	From date of randomization to first occurrence of progression, assessed up to 5 years	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

Name	Time	Method
Metastasis-free survival after initiation of radiation therapy (RT)	Up to 5 years after the date of randomization	Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.
Overall survival	Up to 5 years after the date of randomization
PSMA PET derived predictors of overall survival	Up to 5 years after the date of randomization	Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.
PSMA positron emission tomography (PET) derived predictors of progression-free survival	Up to 5 years after the date of randomization	Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival.
Change in initial treatment intent	Baseline up to 5 years after the date of randomization	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.
Loco-regional progression free survival	Up to 5 years after the date of randomization	Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.

Trial Locations

Locations (1)

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