High-Risk Metachronous Oligometastatic Prostate Cancer Trial

This study is for men aged 18 and older with prostate cancer that has spread to a few (oligometastatic) new spots within the last six months. It compares two approaches: standard hormonal therapy plus Stereotactic Ablative Radiation (SABR) to the cancer spots, versus the same standard treatment with an added 6-month course of niraparib/abiraterone acetate pills and prednisone. The main goal is to see how these treatments affect your PSA (Prostate Specific Antigen) levels after 18 months. This trial is currently recruiting participants.

Study design: This is an interventional study with a planned enrollment of 88 participants. You will be randomly assigned to one of two treatment groups.
What's involved: You will receive either standard hormonal therapy + SABR, or standard therapy + 6 months of niraparib/abiraterone acetate and prednisone. Both groups will have rectal swabs, blood tests for tumor cells and genetic information, and complete quality-of-life surveys.
Compensation: Not stated in the trial record.
Follow-up: Your PSA levels will be evaluated at 18 months to see how well the treatments worked.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

High-Risk Metachronous Oligometastatic Prostate Cancer Trial

Active, Not Recruiting

PHASE2Ages 18+InterventionalTreatment

University of Maryland, Baltimore

~88 participants

Updated 2026-05-06 on ClinicalTrials.gov

What's tested:niraparib/abiraterone acetateStereotactic ablative radiation therapy (SABR)Androgen deprivation therapy (ADT)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

PSA (Prostate Specific Antigen) evaluation at the 18-month progression of both treatment arms

Measured over 18 months

Conditions

Prostate Cancer

Oligometastatic Disease

Where it's being run

1 sites across 1 states

Maryland1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Platelet count ≥100 x 109/L

Creatinine \<2 x upper limit of normal (ULN)

Serum potassium ≥3.5 mmol/L

Serum total bilirubin ≤1.5× ULN or direct bilirubin ≤1 x ULN (Note: In participants with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤1.5 × ULN, participant may be eligible)

AST or ALT ≤3 × ULN 12. Patient must have the ability to understand and the willingness to sign a written informed consent document 13. Able to swallow the study medication tablets whole. 14. While on study medication and for 4 months following the last dose of study medication, a male participant must agree to use condom and an adequate contraception method for female partner (WOCBP) A male participant must agree not to donate sperm while on study treatment and for a minimum of 4 months following the last dose of study medication.

non-muscle invasive bladder cancer.

skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.

malignancy that is considered cured with minimal risk of recurrence.

History or current diagnosis of MDS/AML. 17. Current evidence within 6 months prior to randomization of any of the following:

Receiving antiretroviral therapy that may interfere with the study medication

CD4 count \<350 at screening.

An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.

Human immunodeficiency virus load \>400 copies/mL 24. Active or symptomatic viral hepatitis or chronic liver disease; encephalopathy, ascites or bleeding disorders secondary to hepatic dysfunction. 25. Moderate or severe hepatic impairment (Class B and C per Child-Pugh classification system.

What this trial measures

PSA (Prostate Specific Antigen) evaluation at the 18-month progression of both treatment arms18 months
PSA evaluation of progression at 18-month PSA , defined as PSA \> 0.2 ng/mL in patients initially treated with radical prostatectomy and greater than nadir + 2 ng/mL for patients initially treated with definitive radiation, with testosterone \>100 ng/dl of men who have oligometastatic castration-sensitive prostate cancer with high-risk mutations (TP53, BRCA1/2, PALB2, ATM, BRIP1, CHEK2, FANCA, RAD51B, RAD54L, MUTYH) treated with ADT + SABR MDT (6-mos) versus ADT + SABR MDT + niraparib/abiraterone acetate and prednisone (6-mos).

Trialytics