High-Risk Metachronous Oligometastatic Prostate Cancer Trial

Running, not enrolling · Phase 2

Conditions studied: Prostate Cancer, Oligometastatic Disease

In brief

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.

Key facts

Study ID: NCT06212583
Run by: University of Maryland, Baltimore
People needed: 88
Starts: 2024-04-17
Expected to finish: 2029-12-31
Last updated by the study team: 2026-05-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

≥18 years of age (or the local legal age of consent).
Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone, soft tissue, or extra-pelvic nodal region each < 5 cm or < 250 cm3 that develop within the past 6-months that are seen on imaging. A nodal lesion is defined to include nodal conglomerates located in the same nodal chain such that they can be treated in one SABR field. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or Prostate Specific Membrane Antigen (PSMA) PET-CT scan.
CT or MRI scan within 6 months of enrollment
Bone scan within 6 months of enrollment
Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan)
Must have a high-risk pathogenic mutation (TP53, BRCA1/2, PALB2, ATM, BRIP1, CHEK2, FANCA, RAD51B, RAD54L, MUTYH) by next generation sequencing. ATM mutation enrollment will be capped at 5% of the overall population.
Histologic confirmation of prostate adenocarcinoma (primary or metastatic tumor).
Patient may have had prior systemic therapy and/or ADT so long as testosterone is > 100 ng/dl prior to enrollment
PSA > 0.5 but <50 at enrollment.
Prostate Specific Antigen Doubling Time (PSADT) < 15 months
Baseline testosterone > 100 ng/dl
Patient must have a life expectancy ≥ 12 months.
Patient must have an ECOG performance status ≤ 2.
Adequate hematologic, renal, and hepatic function at screening defined as follows:
Absolute neutrophil count ≥1.5 x 109/L
Hemoglobin ≥9.0 g/dL, independent of transfusions for at least 28 days
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
Patient must have the ability to understand and the willingness to sign a written informed consent document
Able to swallow the study medication tablets whole.
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.

Where it is running

University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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