Actively Recruiting
Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)
Led by Ontario Clinical Oncology Group (OCOG) · Updated on 2026-03-13
162
Participants Needed
3
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.
CONDITIONS
Official Title
Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous biopsy-proven localized prostate adenocarcinoma treated with definitive or salvage radiotherapy at least 2 years before enrollment
- Recurrent oligo-metastatic castrate sensitive prostate cancer with 5 or fewer metastases on all imaging including MRI and PSMA-PET
- All sites of recurrent disease must be treatable with radiotherapy or surgery as judged by the investigator
- Biochemical recurrence defined as PSA 2 nadir + 2 ng/ml after definitive radiotherapy or PSA 2 nadir + 0.2 ng/ml after prostatectomy and adjuvant/salvage radiotherapy
You will not qualify if you...
- Age under 18 years
- ECOG Performance Status of 3 or higher
- PSA level equal to or greater than 20 ng/ml
- Treatment with androgen deprivation therapy within 2 years before enrollment or androgen receptor axis treatment within 6 months
- Prior chemotherapy for prostate cancer or bilateral orchiectomy
- Intracranial or intrathecal metastasis
- Spinal cord compression or spinal intramedullary metastasis
- Prior malignancy unless disease-free for more than 3 years (except non-metastatic, non-melanomatous skin cancer)
- Bilateral hip prosthesis with local disease recurrence and no salvage treatment options
- Known hypersensitivity to ELIGARD or similar GnRH agonist analogs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Actively Recruiting
2
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H8L6
Not Yet Recruiting
3
Jewish General Hospital
Montreal, Quebec, Canada, H1T2M4
Actively Recruiting
Research Team
L
Lisa Rudd-Scott, RN BScN
CONTACT
D
Daryl Solomon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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