drugset / Trial / NCT05404139
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-24
- Primary completion
- 2031-02
- Completion
- 2031-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | — | Oral |