Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)

Jonsson Comprehensive Cancer Center

Status and phase: Terminated; Phase 3

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

Treatments: Radiation: Radiation Therapy; Procedure: Computed Tomography; Other: Fluorine F 18 DCFPyL; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04457245

NCI-2020-03445 (Registry Identifier)

20-000378

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Arm I (dRT)

Active Comparator group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Arm II (18F-DCFPyL, PET/CT, dRT)

Experimental group

Description:

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.

Treatment:

Procedure: Positron Emission Tomography

Other: Fluorine F 18 DCFPyL

Procedure: Computed Tomography

Radiation: Radiation Therapy