NCT04619069Active, not recruitingPhase 1/2
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer: A Randomized Feasibility Study
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 29 Oct 2020
- Start date
- 27 Oct 2020
- Primary completion date
- Dec 2030
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer
- NCT number
- NCT04619069
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 60
- From 27 Oct 2020 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
- Castrate resistant prostate cancer.
Other
- Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
- Evidence of spinal cord compression.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.