PSMA-PET Guided Radiotherapy

Overview

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).

Full Title of Study: “PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2021

Interventions

  • 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.
  • Radiation: Standard-care simulation
    • No PSMA-PET/CT as part of RT treatment planning.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Standard
    • Patient’s receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.

Clinical Trial Outcome Measures

Primary Measures

  • Failure-free survival
    • Time Frame: 5 years
    • Time to failure event

Secondary Measures

  • Acute and delayed toxicities
    • Time Frame: 5 years
    • Rate of Attributable Gr2+ toxicities (CTCAE v4.0)
  • Rate of failure
    • Time Frame: 5 years
    • Event rates
  • Survival
    • Time Frame: 5 years
    • Event rates
  • Health-related quality of life
    • Time Frame: 5 years
    • Qol measures
  • Detection yield of PSMA PET imaging
    • Time Frame: 2 years
    • Rate of new lesions identified on imaging

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Collaborator
    • Progenics Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Cynthia Ménard, MD, M.Sc, 514-890-8254, Cynthia.Menard@umontreal.ca

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