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Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)

Primary Purpose

Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fluorine F 18 DCFPyL
Positron Emission Tomography
Radiation Therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 focused on measuring PSMA, PET/CT, randomized trial, definitive Radiation Therapy, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (dRT)

Arm II (18F-DCFPyL, PET/CT, dRT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Loco-regional progression free survival
Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.
Metastasis-free survival after initiation of radiation therapy (RT)
Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.
Overall survival
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.
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.
PSMA PET derived predictors of overall survival
Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.

Full Information

First Posted
June 30, 2020
Last Updated
January 12, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04457245
Brief Title
Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer
Acronym
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]
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
accrual
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
PSMA, PET/CT, randomized trial, definitive Radiation Therapy, prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (dRT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm II (18F-DCFPyL, PET/CT, dRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo whole body PET/CT
Intervention Type
Other
Intervention Name(s)
Fluorine F 18 DCFPyL
Other Intervention Name(s)
18F-DCFPyL
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo whole body PET/CT
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo standard of care definitive radiation therapy
Primary Outcome Measure Information:
Title
Success rate of definitive radiation therapy (dRT)
Description
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.
Time Frame
From date of randomization to first occurrence of progression, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Loco-regional progression free survival
Description
Diagnosis of local recurrence or pelvic nodal disease (N1) can be obtained by any imaging or biopsy.
Time Frame
Up to 5 years after the date of randomization
Title
Metastasis-free survival after initiation of radiation therapy (RT)
Description
Diagnosis of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy.
Time Frame
Up to 5 years after the date of randomization
Title
Overall survival
Time Frame
Up to 5 years after the date of randomization
Title
Change in initial treatment intent
Description
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.
Time Frame
Baseline up to 5 years after the date of randomization
Title
PSMA positron emission tomography (PET) derived predictors of progression-free survival
Description
Will use Cox-proportional hazards regression to assess PSMA PET predictors of progression-free survival.
Time Frame
Up to 5 years after the date of randomization
Title
PSMA PET derived predictors of overall survival
Description
Will use Cox-proportional hazards regression to assess PSMA PET predictors of overall survival.
Time Frame
Up to 5 years after the date of randomization

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremie Calais
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33962579
Citation
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.
Results Reference
derived

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

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