RecruitingPhase 2NCT05404139

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

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

Sponsor

University Health Network, Toronto

Enrollment

132 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria9

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

Exclusion Criteria4

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