PSMA-PET Guided Radiotherapy

NCT ID: NCT03525288

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2027-05-30

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PSMA -PET/CT simulation

Intervention Type: RADIATION

• 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.

Standard

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

Group Type: ACTIVE_COMPARATOR

Standard-care simulation

Intervention Type: RADIATION

No PSMA-PET/CT as part of RT treatment planning.

Interventions

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.

Intervention Type: RADIATION

Standard-care simulation

No PSMA-PET/CT as part of RT treatment planning.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CSSSL - Cité de la Santé Laval

Laval, Quebec, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

CHU de Québec

Québec, Quebec, Canada

Countries

Canada

References

Belliveau C, Saad F, Duplan D, Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Igidbashian L, Gauthier-Pare AS, Nguyen TV, McLaughlin PY, Keu KV, DaSilva JN, Juneau D, Menard C. Prostate-Specific Membrane Antigen PET-Guided Intensification of Salvage Radiotherapy After Radical Prostatectomy: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2025 Oct 2. doi: 10.1001/jamaoncol.2025.3746. Online ahead of print.

Reference Type: DERIVED

PMID: 41037308 (View on PubMed)

Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Pare AG, Nguyen TV, Duplan D, Keu KV, Saad F, Juneau D, Menard C. PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2023 Jul 15;116(4):779-787. doi: 10.1016/j.ijrobp.2022.12.055. Epub 2023 Jan 11.

Reference Type: DERIVED

PMID: 36639035 (View on PubMed)

Other Identifiers

PERA GU17.1

Identifier Type: REGISTRY

Identifier Source: secondary_id

17.229

Identifier Type: -

Identifier Source: org_study_id