- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457245
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]
Study Overview
Status
Conditions
- Stage II Prostate Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
- Stage IIC Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IIIC Prostate Cancer AJCC v8
- Stage IIA Prostate Cancer AJCC v8
- Stage IIB Prostate Cancer AJCC v8
- Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Undergo standard of care definitive radiation therapy
Other Names:
|
Experimental: 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.
|
Undergo standard of care definitive radiation therapy
Other Names:
Undergo whole body PET/CT
Other Names:
Given IV
Other Names:
Undergo whole body PET/CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of definitive radiation therapy (dRT)
Time Frame: 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.
|
From date of randomization to first occurrence of progression, assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loco-regional progression free survival
Time Frame: 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.
|
Up to 5 years after the date of randomization
|
Metastasis-free survival after initiation of radiation therapy (RT)
Time Frame: Up to 5 years after the date of randomization
|
Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.
|
Up to 5 years after the date of randomization
|
Overall survival
Time Frame: Up to 5 years after the date of randomization
|
Up to 5 years after the date of randomization
|
|
Change in initial treatment intent
Time Frame: 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.
|
Baseline up to 5 years after the date of randomization
|
PSMA positron emission tomography (PET) derived predictors of progression-free survival
Time Frame: Up to 5 years after the date of randomization
|
Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival.
|
Up to 5 years after the date of randomization
|
PSMA PET derived predictors of overall survival
Time Frame: Up to 5 years after the date of randomization
|
Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.
|
Up to 5 years after the date of randomization
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-000378
- NCI-2020-03445 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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