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
Conditions
Keywords
PSMA, PET/CT, randomized trial, definitive Radiation Therapy, prostate cancer
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.
Interventions
PROCEDUREComputed Tomography
Undergo whole body PET/CT
OTHERFluorine F 18 DCFPyL
Given IV
PROCEDUREPositron Emission Tomography
Undergo whole body PET/CT
RADIATIONRadiation Therapy
Undergo standard of care definitive radiation therapy
Sponsors
Progenics Pharmaceuticals, Inc.
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of definitive radiation therapy (dRT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis-free survival after initiation of radiation therapy (RT) | Up to 5 years after the date of randomization | Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy. |
| Overall survival | Up to 5 years after the date of randomization | — |
| Loco-regional progression free survival | 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. |
| PSMA positron emission tomography (PET) derived predictors of progression-free survival | Up to 5 years after the date of randomization | Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival. |
| PSMA PET derived predictors of overall survival | Up to 5 years after the date of randomization | Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival. |
| Change in initial treatment intent | 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. |
Countries
United States
Outcome results
None listed