Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Recruiting
Phase 2
Interventional Study
Metastatic Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 352 (estimated)
- Sponsor
- University Health Network, Toronto · Other
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About This Trial
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 abirat…
Trial Locations
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Eligibility Criteria
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
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Contacts