Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)
- Conditions
- Metastatic Prostate CancerCastration-resistant Prostate Cancer
- Interventions
- Radiation: SBRT
- Registration Number
- NCT04070209
- Lead Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Brief Summary
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.
- Detailed Description
Metastases-directed therapy with stereotactic body radiation therapy (SBRT) is emerging as a new treatment option for solid tumor patients with a limited number of metastases (\< 5) at the time of recurrence/progression, so called oligoprogression therapy. As such, oligoprogression is defined as prostate cancer patients with castration resistance and no metastases (M0CRPC) who are receiving ADT and new generation hormonal therapy (enzalutamide, apalutamide or darolutamide) as standard of care, and who are then progressing to oligometastases. The new generation hormonal therapy used in this study will be darolutamide (ODM-201). The rationale behind this approach has been to delay the start of palliative systemic therapies that are most often toxic and associated with a negative impact on patient's quality of life, as well as being more costly. However, to date, there are no prospective published data or ongoing studies that are looking into non metastatic castration resistant prostate cancer (M0CRPC) patients who progress to oligometastases (oligoprogression). To this end, we are proposing this pilot phase II trial to assess the impact of SBRT on radiological progression-free survival (RPFS) of M0CRPC patients who are receiving darolutamide and progress to oligometastatic disease (oligoprogression).
Prostate cancer patients with castration resistance and no metastases (M0CRPC) diagnosed by bone scan and CT scan or MRI will be recruited in this phase II and initiate darolutamide while continuing on ADT (Part 1 of the study), if not receiving darolutamide prior to study entry already. Patients who then progress to wide spread metastases or metastases situated at locations not amenable to ablative therapy will be excluded and treated with second line therapy as per the treating physician. Patients with oligoprogression (\< 5 mets) and amenable to ablative therapy will be then treated with SBRT or surgery as an ablative therapy if SBRT is not feasible (Part 2 of the study). All patients will continue to receive non-interrupted LHRH agonist, PSA testing every 6-12 weeks and re-imaging every 6 months. Imaging will also be repeated at the appearance of symptoms or at PSA progression, whichever occurs first and this schedule continues until disease progression.
This is the first pilot phase II trial assessing the response of SBRT layered on darolutamide on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression. This phase II will consist of 66 M0CRPC patients treated with darolutamide, of which we anticipate 48 will be eligible for SBRT.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Darolutamide (BAY1841788)+ SBRT SBRT CRPC subjects will receive LHRH agonist in combination with the new generation of hormonal therapy Darolutamide (300mg). Subjects who progress on LHRH + Darolutamide and develop oligometastases will receive SBRT Darolutamide (BAY1841788)+ SBRT Darolutamide (BAY1841788) CRPC subjects will receive LHRH agonist in combination with the new generation of hormonal therapy Darolutamide (300mg). Subjects who progress on LHRH + Darolutamide and develop oligometastases will receive SBRT
- Primary Outcome Measures
Name Time Method Radiographic Progression-free Survival 5 years Time from first day of SBRT until confirmed second radiological progression or start of new antineoplastic therapy
- Secondary Outcome Measures
Name Time Method PSA response 5 years PSA value and onset of biochemical failure will be recorded
Functional Assessment of Cancer Therapy-Prostate 5 years Evaluate the impact of the treatment on the patient's quality of life using the FACT-P questionnaire
Overall Survival 5 years Time from randomization until death from any cause
Quality of Life - Fatigue 5 years Evaluate the impact of the treatment on the patient's quality of life using the Brief Fatigue Inventory (BFI) questionnaire
Quality of Life - Pain 5 years Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire
Toxicity of ODM-201 5 years To determine acute and late toxicity due to ODM-201, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time to Subsequent Systemic Antineoplastic Therapy 5 years Time to the administration of subsequent antineoplastic systemic therapy
Disease Specific Survival 5 years Time from randomization until death due to prostate cancer
Time to Skeletal-related Event (SRE) 5 years Date of first SRE will be recorded
Local Control 5 years To evaluate the impact of SBRT on oligometastases progression by radiographic imaging or the start of new antineoplastic therapy.
Trial Locations
- Locations (10)
Prostate Cancer Centre
🇨🇦Calgary, Alberta, Canada
Centre of Applied Urology Research
🇨🇦Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Service d'urologie et Centre de la prostate
🇨🇦Longueuil, Quebec, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
Sir Mortimer JGH
🇨🇦Montréal, Quebec, Canada
L'Hôtel-Dieu de Québec (CHUQ)
🇨🇦Québec city, Quebec, Canada
Hôpital Fleurimont (CHUS)
🇨🇦Sherbrooke, Quebec, Canada
Centre hospitalier affilié universitaire régional (CHAUR)
🇨🇦Trois-Rivières, Quebec, Canada