NCT06212583

High-Risk Metachronous Oligometastatic Prostate Cancer Trial

A Randomized Trial of High-risK metachroNous oligometastatIc Prostate Cancer With hiGh-risk Mutations Treated witH meTastasiS Directed Therapy and Niraparib/Abiraterone Acetate and Prednisone (KNIGHTS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.

Detailed description

In this trial all participants will be randomized to one of the two groups. You will be randomly assigned (by chance, like the flip of a coin) to one of the two groups: 1: Standard of care treatment (hormonal therapy + SABR to the metastatic lesions) or 2: Standard of care treatment + 6-months of niraparib/abiraterone acetate combination pills and prednisone. Participants in both groups will receive rectal swabs and various blood tests to assess circulating tumor cells, genomic sequencing, and tumor markers. Both groups will also participate in quality-of-life surveys

Conditions

• Prostate Cancer
• Oligometastatic Disease

Interventions

Type	Name	Description
DRUG	niraparib/abiraterone acetate	Patients on Arm 2 to receive drug for 6 months
RADIATION	Stereotactic ablative radiation therapy (SABR)	Both arms will receive SABR
DRUG	Androgen deprivation therapy (ADT)	All ADT is provided as best prescribed for patient per their medical oncologist.

Timeline

• Start date: 2024-04-17
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-01-19
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study