PSMA-PET Guided Radiotherapy (PSMA-PETgRT)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: PSMA -PET/CT simulation; Radiation: Standard-care simulation

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Laval, Quebec, Canada
      • CSSSL - Cité de la Santé Laval
    • Montréal, Quebec, Canada
      • Centre Hospitalier de l'Université de Montréal
    • Québec, Quebec, Canada
      • CHU de Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure-free survival	Time to failure event	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Progenics Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 17.229; PERA GU17.1 (Registry Identifier: PERA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No