Investigating a new treatment approach for metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of adding an androgen receptor pathway inhibitor, abiraterone, to standard radiation and hormone therapy for patients with oligometastatic prostate cancer. Participants are randomly assigned to receive either standard treatment or the combination treatment for 8-9 months, followed by routine follow-ups for up to 5 years. The goal is to determine if this combination improves quality of life compared to standard care alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years
2. Able to provide informed consent
3. Histologic diagnosis of prostate adenocarcinoma
4. ECOG performance status 0-2
5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases

   1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
   2. Additional metastases can be detectable by PSMA PET only
6. All sites of disease are amenable to and can be safely treated with radiotherapy
7. Patients decline continuous use of ADT

Exclusion Criteria (for all patients):

1. Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT

   a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3.
2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
3. Prior use of salvage systemic therapy
4. Evidence of spinal cord compression

Exclusion Criteria (for Arm 4 only, after randomization)

1. ALT/AST \> 3 x ULN
2. History of myasthenia gravis or active myasthenia gravis
3. History of ocular myasthenia or active ocular myasthenia

Where it's running

• Princess Margaret Cancer Center
  Toronto, Ontario, Canada Recruiting
• Sunnybrook Research Institute
  Toronto, Ontartio, Canada Active not recruiting

Study contacts

• Study coordinator: Rachel Glicksman, MD
• Email: rachel.glicksman@uhn.ca
• Phone: 416-946-4961

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combined treatment approach in metastatic prostate cancer using AZD2265 (FPI-2265) with palacaparib or docetaxel

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.