Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligo… (NCT05404139) | Clinical Trial Compass
RecruitingPhase 2
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Canada132 participantsStarted 2023-05-24
Plain-language summary
This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor 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) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.
Who can participate
Age range
18 Years – 100 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.