RecruitingPhase 2NCT06212583

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)


Sponsor

University of Maryland, Baltimore

Enrollment

88 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is for men with prostate cancer that has spread to a small number of new spots (called oligometastatic disease) after initial treatment, who also carry certain high-risk inherited gene mutations. The study is testing whether targeted radiation (called SABR) to those few spots can delay or prevent further spread and improve outcomes in this genetically high-risk group. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer - Your cancer has developed 1 to 3 new tumor spots (or up to 5 on advanced imaging) in the past 6 months, each smaller than 5 cm - You carry a high-risk gene mutation such as BRCA1, BRCA2, TP53, ATM, PALB2, or similar - Your PSA is between 0.5 and 50 - Your PSA doubling time is less than 15 months - Your testosterone level is above 100 ng/dL - You have a life expectancy of at least 12 months **You may NOT be eligible if...** - You do not carry one of the specified gene mutations - Your testosterone is suppressed from hormone therapy (below 100 ng/dL) - You have more than 3 tumor spots (or 5 on PET scan) - Your PSA is below 0.5 or above 50 - You have certain other serious health conditions that would prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGniraparib/abiraterone acetate

Patients on Arm 2 to receive drug for 6 months

RADIATIONStereotactic ablative radiation therapy (SABR)

Both arms will receive SABR

DRUGAndrogen deprivation therapy (ADT)

All ADT is provided as best prescribed for patient per their medical oncologist.


Locations(1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

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NCT06212583


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