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

Stage III Prostate Cancer AJCC v8 Clinical Trial

— PSMA-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]

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04457245
• Other study ID #: 20-000378
• Secondary ID: NCI-2020-03445
• Status: Terminated
• Phase: Phase 3
• Start date: August 14, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: January 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• 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

Intervention

Procedure:
• Computed Tomography
Undergo whole body PET/CT

Other:
• Fluorine F 18 DCFPyL
Given IV

Procedure:
• Positron Emission Tomography
Undergo whole body PET/CT

Radiation:
• Radiation Therapy
Undergo standard of care definitive radiation therapy

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of definitive radiation therapy (dRT)	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.	From date of randomization to first occurrence of progression, assessed up to 5 years
Secondary	Loco-regional progression free survival	Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.	Up to 5 years after the date of randomization
Secondary	Metastasis-free survival after initiation of radiation therapy (RT)	Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.	Up to 5 years after the date of randomization
Secondary	Overall survival		Up to 5 years after the date of randomization
Secondary	Change in initial treatment intent	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.	Baseline up to 5 years after the date of randomization
Secondary	PSMA positron emission tomography (PET) derived predictors of progression-free survival	Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival.	Up to 5 years after the date of randomization
Secondary	PSMA PET derived predictors of overall survival	Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.	Up to 5 years after the date of randomization