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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03445 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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accrual
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (dRT) | Active Comparator | 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. |
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| Arm II (18F-DCFPyL, PET/CT, dRT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo whole body PET/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Metastasis-free survival after initiation of radiation therapy (RT) |
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Inclusion Criteria:
Adult male 18 years or older
Histopathologically-proven PCa
Unfavorable IR to HR disease:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremie Calais | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38664019 | Derived | Nikitas J, Lam E, Booker KA, Fendler WP, Eiber M, Hadaschik B, Herrmann K, Hirmas N, Lanzafame H, Stuschke M, Czernin J, Steinberg ML, Nickols NG, Kishan AU, Calais J. Randomized Trial of Prostate-Specific Membrane Antigen PET/CT Before Definitive Radiotherapy for Unfavorable Intermediate- and High-Risk Prostate Cancer (PSMA-dRT Trial). J Nucl Med. 2024 Jul 1;65(7):1076-1079. doi: 10.2967/jnumed.123.267004. | |
| 33962579 |
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| Fluorine F 18 DCFPyL | Other | Given IV |
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| Positron Emission Tomography | Procedure | Undergo whole body PET/CT |
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| Radiation Therapy | Radiation | Undergo standard of care definitive radiation therapy |
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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 | Up to 5 years after the date of randomization |
| 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 |
| 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 |
| 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 |
| Derived |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 6, 2023 | Nov 1, 2023 | 8 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
| D009682 | Magnetic Resonance Spectroscopy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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