Actively Recruiting
Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)
Led by Sir Mortimer B. Davis - Jewish General Hospital · Updated on 2024-12-04
66
Participants Needed
10
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression.
CONDITIONS
Official Title
Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- M0CRPC with ongoing androgen deprivation therapy via LHRH agonist or bilateral orchiectomy
- Serum testosterone level 64 1.7 nmol/L (50 ng/dL) at screening
- PSA progression with at least two rising PSA values one week apart; PSA 64 2 bcg/L (2 ng/mL) at screening
- PSA doubling time of 10 months or less
- No metastases on conventional imaging (CT/MRI plus bone scan) at study entry
- Prior chemotherapy allowed if given as adjuvant after radical therapy
- ECOG performance status 0-1 or Karnofsky performance status > 80%
- Estimated life expectancy of at least 6 months
- Ability to swallow study drug and comply with study
- No prior use of other androgen receptor targeted therapies such as abiraterone, enzalutamide, or apalutamide
- Five or fewer metastatic sites on imaging
- Four or fewer tumors in any single organ system, excluding brain
- All metastatic sites must be treatable with SBRT and not previously irradiated for those metastases
- Confirmatory imaging or biopsy recommended for suspicious lesions in unusual locations
You will not qualify if you...
- Severe concurrent disease, infection, or comorbidity making participation unsafe
- Presence of distant metastases beyond oligoprogression; isolated pelvic nodal disease below iliac bifurcation not excluded
- Another malignancy in the past 5 years except treated non-melanoma skin cancer
- Low blood counts at screening (neutrophils < 1500/bcL, platelets < 100,000/bcL, hemoglobin < 9 g/dL)
- Elevated liver enzymes (ALT or AST > 2.5 times upper limit) or bilirubin > 1.5 times upper limit
- Creatinine > 2 times upper limit of normal
- Significant cardiovascular disease within 6 months including stroke, heart attack, uncontrolled angina, bypass surgery, heart failure class 3 or 4, heart block without pacemaker, uncontrolled hypertension, or bradycardia
- Gastrointestinal disorders affecting drug absorption
- Major surgery within 4 weeks before enrollment
- Active viral hepatitis, HIV, or chronic liver disease
- Use of opiate pain medications for prostate cancer pain within 4 weeks
- Radiation therapy to primary tumor within 3 weeks
- Radiation or radionuclide therapy for metastases
- Untreated primary prostate cancer
- Hormone-na�efve prostate cancer
- Treatment with estrogens or androgen receptor inhibitors within 4 weeks
- Use of systemic biologic or anti-tumor agents other than bone-targeted or GnRH analogues within 4 weeks
- Prior investigational agents targeting androgen synthesis or receptor
- Known allergies or contraindications to darolutamide or GnRH agonists
- Use of investigational agents or certain herbal or corticosteroid products within 4 weeks
- Any condition interfering with participation or safety
- Unable to swallow study medication or comply with requirements
- Brain metastases or leptomeningeal disease
- More than five metastases or more than four in the same organ
- Prior radiation therapy to areas considered for SBRT treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
Actively Recruiting
2
Centre of Applied Urology Research
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
4
Service d'urologie et Centre de la prostate
Longueuil, Quebec, Canada, J4V 2H3
Actively Recruiting
5
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
6
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
7
Sir Mortimer JGH
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
8
L'Hôtel-Dieu de Québec (CHUQ)
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
9
Hôpital Fleurimont (CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
10
Centre hospitalier affilié universitaire régional (CHAUR)
Trois-Rivières, Quebec, Canada, G8Z 3R9
Actively Recruiting
Research Team
P
Paola Diego
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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