Back to resultsIntermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
SBRT
Hormone therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years.
- Able to provide informed consent.
- Histologic diagnosis of prostate adenocarcinoma.
- ECOG performance status 0-1.
- Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
- Up to a maximum of 3 PSMA avid areas of metastatic disease.
- For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be > 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
- All sites of disease are amenable to and can be safely treated with SBRT.
Exclusion Criteria:
- Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
- History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
- Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
- Castrate resistant prostate cancer.
- Evidence of spinal cord compression.
Sites / Locations
- Odette Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1: Standard of Care
Arm 2: SBRT to mets
Arm Description
Intermittent Hormone treatment (minimum of 8 months)
Intermittent Hormone treatment (minimum of 8 months) + SBRT to all sites of metastatic disease
Outcomes
Primary Outcome Measures
Proportion of eligible patients who enroll onto the study
The primary purpose of this feasibility study is to measure the proportion of patients who are willing to enter this randomized trial
Secondary Outcome Measures
Side Effects and Effectiveness
An important secondary purpose is to measure the side effects and effectiveness of adding stereotactic radiotherapy to all sites of disease to intermittent hormone therapy compared to intermittent hormone therapy alone, using CTCAE v.5
Full Information
NCT ID
NCT04619069
First Posted
October 29, 2020
Last Updated
December 1, 2020
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04619069
Brief Title
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
Official Title
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer: A Randomized Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
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 study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan
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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Standard of Care
Arm Type
Active Comparator
Arm Description
Intermittent Hormone treatment (minimum of 8 months)
Arm Title
Arm 2: SBRT to mets
Arm Type
Experimental
Arm Description
Intermittent Hormone treatment (minimum of 8 months)
+ SBRT to all sites of metastatic disease
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
SBRT to all sites of metastatic disease as seen on PSMA PET scan
Intervention Type
Drug
Intervention Name(s)
Hormone therapy
Intervention Description
Intermittent Hormone Therapy per physician discretion (Min. 8 months)
Primary Outcome Measure Information:
Title
Proportion of eligible patients who enroll onto the study
Description
The primary purpose of this feasibility study is to measure the proportion of patients who are willing to enter this randomized trial
Time Frame
Through accrual completion, approx 2 years
Secondary Outcome Measure Information:
Title
Side Effects and Effectiveness
Description
An important secondary purpose is to measure the side effects and effectiveness of adding stereotactic radiotherapy to all sites of disease to intermittent hormone therapy compared to intermittent hormone therapy alone, using CTCAE v.5
Time Frame
Through study completion, approx 5 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate Cancer Patients only. Males only.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years.
Able to provide informed consent.
Histologic diagnosis of prostate adenocarcinoma.
ECOG performance status 0-1.
Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
Up to a maximum of 3 PSMA avid areas of metastatic disease.
For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be > 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
All sites of disease are amenable to and can be safely treated with SBRT.
Exclusion Criteria:
Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
Castrate resistant prostate cancer.
Evidence of spinal cord compression.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Cheung
Phone
4164805000
Email
patrick.cheung@sunnybrook.ca
Facility Information:
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Cheung
Phone
4164805000
Email
patrick.cheung@sunnybrook.ca
12. IPD Sharing Statement
Learn more about this trial
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
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