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Clinical Trials in Canada / NCT04619069
Active, not recruiting Phase 1/2

Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer

NCT04619069 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1/2
Started
2020-10-27
Last updated
2026-06-26

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SBRTHormone therapy

SBRT: SBRT to all sites of metastatic disease as seen on PSMA PET scan

Hormone therapy: Intermittent Hormone Therapy per physician discretion (Min. 8 months)

Study 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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age \> 18 years. 2. Able to provide informed consent. 3. Histologic diagnosis of prostate adenocarcinoma. 4. ECOG performance status 0-1. 5. 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. 6. Up to a maximum of 3 PSMA avid areas of metastatic disease. 7. 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. 8. All sites of disease are amenable to and can be safely treated with SBRT. Exclusion Criteria: 1. Significant comorbidities rendering patient not suitable for ADT and/or SBRT. 2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer. 3. 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. 4. Castrate resistant prostate cancer. 5. Evidence of spinal cord compression.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Odette Cancer Centre Toronto Ontario

More Sunnybrook Health Sciences Centre trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04619069 on ClinicalTrials.gov ↗ ← All trials in Canada