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New treatment option for Metastatic Prostate Cancer
Official title Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
ClinicalTrials.gov ID: NCT05404139
What this study is testing
What is Enzalutamide?
Enzalutamide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, men only
You may be able to join if
- 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
You likely can't join if
- Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT
- History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
- Prior use of salvage systemic therapy
- Evidence of spinal cord compression
See the full eligibility 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
- Patients decline continuous use of ADT
- Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT
- History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
- Prior use of salvage systemic therapy
- Evidence of spinal cord compression
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
- Toronto, Ontartio, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada; Toronto, Ontartio, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.