Back to resultsMolecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer (MIDAS-Prostate)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Image-guided Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, adenocarcinoma, PSMA PET, radical prostatectomy, recurrence
Eligibility Criteria
Inclusion Criteria:
- Men older than 18 years old.
- Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
- Previous radical prostatectomy.
- Biochemical relapse with local or regional recurrence proven on PSMA PET.
- Five or less positive nodes on the PSMA PET.
- ECOG 0-1
Exclusion Criteria:
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis
Sites / Locations
- Princess Margaret Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Molecular Imaging Informed Radiation Dose Escalation and De-escalation
Arm Description
Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.
Outcomes
Primary Outcome Measures
Grade ≥2 Toxicity for GU
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Secondary Outcome Measures
Biochemical Failure Free Survival
Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels
Patient-reported quality-of-life assessed by EPIC-26
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Full Information
NCT ID
NCT05328505
First Posted
April 7, 2022
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05328505
Brief Title
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Acronym
MIDAS-Prostate
Official Title
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
August 2028 (Anticipated)
Study Completion Date
August 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, adenocarcinoma, PSMA PET, radical prostatectomy, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Molecular Imaging Informed Radiation Dose Escalation and De-escalation
Arm Type
Experimental
Arm Description
Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.
Intervention Type
Radiation
Intervention Name(s)
Image-guided Radiotherapy
Intervention Description
de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician.
Primary Outcome Measure Information:
Title
Grade ≥2 Toxicity for GU
Description
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
Baseline to 5-year follow-up
Secondary Outcome Measure Information:
Title
Biochemical Failure Free Survival
Description
Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels
Time Frame
Baseline to 5-year follow-up
Title
Patient-reported quality-of-life assessed by EPIC-26
Description
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Time Frame
Baseline to 5-year follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men older than 18 years old.
Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
Previous radical prostatectomy.
Biochemical relapse with local or regional recurrence proven on PSMA PET.
Five or less positive nodes on the PSMA PET.
ECOG 0-1
Exclusion Criteria:
Presence of para-aortic lymph nodes or distant metastasis.
Chronic pelvic inflammatory disease.
Contraindication for radiation treatment.
Previous radiation treatment within the pelvis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Srinivas Raman, MD
Phone
416-946-2320
Email
srinivas.raman@rmp.uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivas Raman, MD
Phone
416-946-2320
Email
srinivas.raman@rmp.uhn.ca
12. IPD Sharing Statement
Learn more about this trial
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
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