PSMA-PET Guided Radiotherapy

Last updated: March 12, 2025
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Urologic Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

Standard-care simulation

PSMA -PET/CT simulation

Clinical Study ID

NCT03525288
17.229
PERA GU17.1
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigationaltrials.

  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:

  6. Oligometastases (≤5) (regional or distant) identified on conventional staging,with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, directinvolvement of adjacent spinal segments would still be considered as "one"tumour. For nodal metastases, more than one involved lymph node in the sameipsilateral nodal region/chain would still count as "one" tumour. Defined nodalregions for this protocol include inguinal, external iliac, internal iliac,common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posteriorcervical, and axillary. Metastases in all other organs that are within 1cm ofeach other will be considered as "one" tumour.

  7. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer andCAPRA score 6-10.

  8. Subjects with a prior history of treated prostate cancer (RP or RT), andbiochemical failure (Phoenix-RT or>0.2ng/ml-RP)

  9. Standard staging (bone scan, CT pelvis) within 12 weeks of consent.

Exclusion

Exclusion Criteria:

  1. Prior androgen deprivation therapy terminated < 12 months prior to enrollment.

  2. Prior or planned PET scan.

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Standard-care simulation
Phase: 2/3
Study Start date:
May 15, 2018
Estimated Completion Date:
May 30, 2027

Connect with a study center

  • CSSSL - Cité de la Santé Laval

    Laval, Quebec
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec
    Canada

    Site Not Available

  • CHU de Québec

    Québec, Quebec
    Canada

    Site Not Available

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