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

NCT ID: NCT04457245

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2023-01-10

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm I (dRT)

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.

Group Type: ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type: RADIATION

Undergo standard of care definitive radiation therapy

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

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.

Group Type: EXPERIMENTAL

Computed Tomography

Intervention Type: PROCEDURE

Undergo whole body PET/CT

Fluorine F 18 DCFPyL

Intervention Type: OTHER

Given IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo whole body PET/CT

Radiation Therapy

Intervention Type: RADIATION

Undergo standard of care definitive radiation therapy

Interventions

Computed Tomography

Undergo whole body PET/CT

Intervention Type: PROCEDURE

Fluorine F 18 DCFPyL

Given IV

Intervention Type: OTHER

Positron Emission Tomography

Undergo whole body PET/CT

Intervention Type: PROCEDURE

Radiation Therapy

Undergo standard of care definitive radiation therapy

Intervention Type: RADIATION

Other Intervention Names

CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT; CT Scan; tomography; 18F-DCFPyL; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; Radiotherapy; RT; Therapy, Radiation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremie Calais

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

References

Calais J, Zhu S, Hirmas N, Eiber M, Hadaschik B, Stuschke M, Herrmann K, Czernin J, Kishan AU, Nickols NG, Elashoff D, Fendler WP. Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol. BMC Cancer. 2021 May 7;21(1):512. doi: 10.1186/s12885-021-08026-w.

Reference Type: DERIVED

PMID: 33962579 (View on PubMed)

Other Identifiers

NCI-2020-03445

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-000378

Identifier Type: -

Identifier Source: org_study_id