PSMA-PET Guided Radiotherapy (PSMA-PETgRT)

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Standard-care simulation; Radiation: PSMA -PET/CT simulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03525288

17.229

PERA GU17.1 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

PSMA-PETgRT

Experimental group

Description:

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.

Treatment:

Radiation: PSMA -PET/CT simulation

Standard

Active Comparator group

Description:

Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.

Treatment:

Radiation: Standard-care simulation