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

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ClinicalTrials.gov Identifier: NCT04457245
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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).

Condition or disease Intervention/treatment Phase
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 Procedure: Computed Tomography Other: Fluorine F 18 DCFPyL Procedure: Positron Emission Tomography Radiation: Radiation Therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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]
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
Radiation: Radiation Therapy
Undergo standard of care definitive radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

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.
Procedure: Computed Tomography
Undergo whole body PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Other: Fluorine F 18 DCFPyL
Given IV
Other Name: 18F-DCFPyL

Procedure: Positron Emission Tomography
Undergo whole body PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Radiation: Radiation Therapy
Undergo standard of care definitive radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall survival [ Time Frame: Up to 5 years after the date of randomization ]
  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457245


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Jeremie Calais    310-825-3617    jcalais@mednet.ucla.edu   
Principal Investigator: Jeremie Calais         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Progenics Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04457245    
Other Study ID Numbers: 20-000378
NCI-2020-03445 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-000378 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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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
Keywords provided by Jonsson Comprehensive Cancer Center:
PSMA
PET/CT
randomized trial
definitive Radiation Therapy
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs