NCT05404139RecruitingPhase 2
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- First submitted
- 19 May 2022
- Start date
- 24 May 2023
- Primary completion date
- Feb 2031
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT05404139
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 352
- From 24 May 2023 to the primary completion date, Feb 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of salvage systemic therapy
Other illness
- 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
Lab values
- ALT/AST \> 3 x ULN
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.