PSMA-PET Guided Radiotherapy

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: PSMA -PET/CT simulation; Radiation: Standard-care simulation

• Registration Number: NCT03525288
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-05-14
• Study Start: 2018-05-15
• Study First Posted: 2018-05-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-05-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSMA-PETgRT	PSMA -PET/CT simulation	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.
Standard	Standard-care simulation	Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.

Primary Outcome Measures

Name	Time	Method
Failure-free survival	5 years	Time to failure event

Secondary Outcome Measures

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

Trial Locations

Locations (3)

CHU de Québec; 🇨🇦 Québec, Quebec, Canada

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada

CSSSL - Cité de la Santé Laval; 🇨🇦 Laval, Quebec, Canada