Back to resultsPSMA-PET Guided Radiotherapy (PSMA-PETgRT)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PSMA -PET/CT simulation
Standard-care simulation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
- Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
- ECOG 0-1
- Charlson Cormobidity Index ≤ 4
High-risk of distant metastases as defined by any of:
- 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.
- Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
- Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
- Standard staging (bone scan, CT pelvis) within 12 weeks of consent.
Exclusion Criteria:
- Prior androgen deprivation therapy terminated < 12 months prior to enrollment.
- Prior or planned PET scan.
Sites / Locations
- CSSSL - Cité de la Santé Laval
- Centre Hospitalier de l'Université de Montréal
- CHU de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PSMA-PETgRT
Standard
Arm 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.
Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.
Outcomes
Primary Outcome Measures
Failure-free survival
Time to failure event
Secondary Outcome Measures
Acute and delayed toxicities
Rate of Attributable Gr2+ toxicities (CTCAE v4.0)
Rate of failure
Event rates
Survival
Event rates
Health-related quality of life
Qol measures
Detection yield of PSMA PET imaging
Rate of new lesions identified on imaging
Full Information
NCT ID
NCT03525288
First Posted
March 19, 2018
Last Updated
September 5, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Progenics Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03525288
Brief Title
PSMA-PET Guided Radiotherapy
Acronym
PSMA-PETgRT
Official Title
PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Progenics Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomly selected from a standard-care cohort.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSMA-PETgRT
Arm Type
Experimental
Arm 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.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.
Intervention Type
Radiation
Intervention Name(s)
PSMA -PET/CT simulation
Intervention Description
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
Intervention Name(s)
Standard-care simulation
Intervention Description
No PSMA-PET/CT as part of RT treatment planning.
Primary Outcome Measure Information:
Title
Failure-free survival
Description
Time to failure event
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Acute and delayed toxicities
Description
Rate of Attributable Gr2+ toxicities (CTCAE v4.0)
Time Frame
5 years
Title
Rate of failure
Description
Event rates
Time Frame
5 years
Title
Survival
Description
Event rates
Time Frame
5 years
Title
Health-related quality of life
Description
Qol measures
Time Frame
5 years
Title
Detection yield of PSMA PET imaging
Description
Rate of new lesions identified on imaging
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
ECOG 0-1
Charlson Cormobidity Index ≤ 4
High-risk of distant metastases as defined by any of:
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.
Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
Standard staging (bone scan, CT pelvis) within 12 weeks of consent.
Exclusion Criteria:
Prior androgen deprivation therapy terminated < 12 months prior to enrollment.
Prior or planned PET scan.
Facility Information:
Facility Name
CSSSL - Cité de la Santé Laval
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
CHU de Québec
City
Québec
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
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PSMA-PET Guided Radiotherapy
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