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OncoMatch/Clinical Trials/NCT05404139

Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

Is NCT05404139 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Enzalutamide for metastatic prostate cancer.

Phase 2RecruitingUniversity Health Network, TorontoNCT05404139Data as of Jun 2026Location: Canada

Treatment: EnzalutamideThis 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.

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Extracted eligibility criteria

Treatments studied

Endocrine / hormonal

Enzalutamide

Cancer type

Prostate Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 100
Male only

Prior therapy

Cannot have received: salvage systemic therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT05404139 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior salvage systemic therapy disqualifies patients from enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Is there an age limit?

Yes. Patients must be 100 years or younger.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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