Tests abiraterone and atorvastatin added to radiation and hormone therapy for prostate cancer
Tests extra abiraterone and atorvastatin with radiation and hormone therapy in men with prostate cancer.
Plain-language title generated from the registry record
Registry title: Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Key facts
- Where
- Toronto, CanadaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05404139, who can take part
Where in Canada
- Princess Margaret Cancer CenterToronto, CanadaTaking people
- Sunnybrook Research InstituteToronto, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT05404139
- Record updated
- 27 July 2026
- Original description
This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life.Read full original descriptionShow less
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate
This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life.
Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.
Inclusion: Age > 18 years; Able to provide informed consent; Histologic diagnosis of prostate adenocarcinoma; ECOG performance status 0-2; Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases; Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR); Additional metastases can be detectable by PSMA PET only; All sites of disease are amenable to and can be safely treated with radiotherapy; Patients decline continuous use of ADT.
Exclusion: Prior use of salvage systemic therapy; History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively; History of myasthenia gravis or active myasthenia gravis; History of ocular myasthenia or active ocular myasthenia; ALT/AST > 3 x ULN; Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT; 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; Evidence of spinal cord compression.