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PSMA-PETgRT: PSMA-PET Guided Radiotherapy

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03525288
Collaborator
Progenics Pharmaceuticals, Inc. (Industry)
130
Enrollment
3
Locations
2
Arms
95.5
Anticipated Duration (Months)
43.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Radiation: PSMA -PET/CT simulation
  • Radiation: Standard-care simulation
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients are randomly selected from a standard-care cohort.Patients are randomly selected from a standard-care cohort.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer
Actual Study Start Date :
May 15, 2018
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Failure-free survival [5 years]

    Time to failure event

Secondary Outcome Measures

  1. Acute and delayed toxicities [5 years]

    Rate of Attributable Gr2+ toxicities (CTCAE v4.0)

  2. Rate of failure [5 years]

    Event rates

  3. Survival [5 years]

    Event rates

  4. Health-related quality of life [5 years]

    Qol measures

  5. Detection yield of PSMA PET imaging [2 years]

    Rate of new lesions identified on imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  6. 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.

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

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

  9. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CSSSL - Cité de la Santé Laval Laval Quebec Canada
2 Centre Hospitalier de l'Université de Montréal Montréal Quebec Canada
3 CHU de Québec Québec Quebec Canada

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT03525288
Other Study ID Numbers:
  • 17.229
  • PERA GU17.1
First Posted:
May 15, 2018
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 9, 2022