PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer

Condition: Prostate Cancer


  • Radiation: PSMA -PET/CT simulation
  • Radiation: Standard-care simulation

Purpose: 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).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03525288

Sponsor: Centre hospitalier de l’Université de Montréal (CHUM)

Primary Outcome Measures:

  • Measure: Failure-free survival
  • Time Frame: 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Acute and delayed toxicities
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Rate of failure
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Survival
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Health-related quality of life
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Detection yield of PSMA PET imaging
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 130

Study Start Date: May 15, 2018

Phase: Phase 2/Phase 3


  • Age: minimum 18 Years maximum N/A
  • Gender: All

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:
  6. 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.
  7. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-
  8. Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
  9. 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.


  • Cynthia Ménard, MD, M.Sc
  • 514-890-8254


  • Centre Hospitalier de l’Université de Montréal
  • Montréal Quebec Canada

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