Study Stopped
accrual
Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer
PSMA-dRT
Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT]
2 other identifiers
interventional
54
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedJanuary 17, 2023
January 1, 2023
2.4 years
June 30, 2020
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Loco-regional progression free survival
Up to 5 years after the date of randomization
Metastasis-free survival after initiation of radiation therapy (RT)
Up to 5 years after the date of randomization
Overall survival
Up to 5 years after the date of randomization
Change in initial treatment intent
Baseline up to 5 years after the date of randomization
PSMA positron emission tomography (PET) derived predictors of progression-free survival
Up to 5 years after the date of randomization
- +1 more secondary outcomes
Study Arms (2)
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.
Interventions
Undergo whole body PET/CT
Undergo whole body PET/CT
Undergo standard of care definitive radiation therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Related Publications (1)
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.
PMID: 33962579DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie Calais
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
August 14, 2020
Primary Completion
January 10, 2023
Study Completion
January 10, 2023
Last Updated
January 17, 2023
Record last verified: 2023-01