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PSMA-PET Guided Radiotherapy (PSMA-PETgRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03525288
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : May 4, 2020
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: PSMA -PET/CT simulation Radiation: Standard-care simulation Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomly selected from a standard-care cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PSMA-PETgRT
PSMA-PET/CT imaging is performed during treatment planning. Treating physicians are informed of test results and advised to include up to 5 PSMA-PET avid sites distant to the prostate gland, if present, in the radiotherapy treatment plan.
Radiation: PSMA -PET/CT simulation
  • PET/CT simulation.
  • If no additional lesions detected: RT as planned per standard care.
  • If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT.
  • If PSMA-PET/CT imaging consistent with widely metastatic disease (>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged.

Active Comparator: Standard
Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.
Radiation: Standard-care simulation
No PSMA-PET/CT as part of RT treatment planning.

Primary Outcome Measures :
  1. Failure-free survival [ Time Frame: 5 years ]
    Time to failure event

Secondary Outcome Measures :
  1. Acute and delayed toxicities [ Time Frame: 5 years ]
    Rate of Attributable Gr2+ toxicities (CTCAE v4.0)

  2. Rate of failure [ Time Frame: 5 years ]
    Event rates

  3. Survival [ Time Frame: 5 years ]
    Event rates

  4. Health-related quality of life [ Time Frame: 5 years ]
    Qol measures

  5. Detection yield of PSMA PET imaging [ Time Frame: 2 years ]
    Rate of new lesions identified on imaging

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
  2. Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
  3. ECOG 0-1
  4. Charlson Cormobidity Index ≤ 4
  5. High-risk of distant metastases as defined by any of:

    1. Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour.
    2. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
    3. Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
  6. Standard staging (bone scan, CT pelvis) within 12 weeks of consent.

Exclusion Criteria:

  1. Prior androgen deprivation therapy terminated < 12 months prior to enrollment.
  2. Prior or planned PET scan.

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 identifier (NCT number): NCT03525288

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Contact: Cynthia Ménard, MD, M.Sc 514-890-8254

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Canada, Quebec
CSSSL - Cité de la Santé Laval Recruiting
Laval, Quebec, Canada
Contact: Danny Duplan, MD    450-668-1010   
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada
Contact: Diane Trudel    514-890-8000 ext 26906   
CHU de Québec Not yet recruiting
Québec, Quebec, Canada
Contact: Eric Vigneault, MD    418-691-5264      
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Progenics Pharmaceuticals, Inc.
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM) Identifier: NCT03525288    
Other Study ID Numbers: 17.229
PERA GU17.1 ( Registry Identifier: PERA )
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases