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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

High-Risk Metachronous Oligometastatic Prostate Cancer Trial (NCT06212583) is a Phase 2 interventional studying Prostate Cancer and Oligometastatic Disease, sponsored by University of Maryland, Baltimore. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Prostate Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 88 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Prostate Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. ≥18 years of age (or the local legal age of consent). 2. 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. 1. CT or MRI scan within 6 months of enrollment 2. Bone scan within 6 months of enrollment 3. 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) 3. 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. 4. Histologic confirmation of prostate adenocarcinoma (primary or metastatic tumor). 5. Patient may have had previous cancer treatment that works throughout the body (like chemotherapy) and/or ADT so long as testosterone is \> 100 ng/dl prior to enrollment 6. PSA \> 0.5 but \<50 at enrollment. 7. Prostate Specific Antigen Doubling Time (PSADT) \< 15 months 8. Baseline testosterone \> 100 ng/dl 9. Patient must have a life expectancy ≥ 12 months. 10. Patient must have an ECOG performance status ≤ 2. 11. Adequate hematologic, renal, and hepatic function at screening defined as follows: • Absolute neutrophil count ≥1.5 x 109/L • blood count (hemoglobin) at least 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. ≥18 years of age (or the local legal age of consent). 2. 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. 1. CT or MRI scan within 6 months of enrollment 2. Bone scan within 6 months of enrollment 3. 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) 3. 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. 4. Histologic confirmation of prostate adenocarcinoma (primary or metastatic tumor). 5. Patient may have had prior systemic therapy and/or ADT so long as testosterone is \> 100 ng/dl prior to enrollment 6. PSA \> 0.5 but \<50 at enrollment. 7. Prostate Specific Antigen Doubling Time (PSADT) \< 15 months 8. Baseline testosterone \> 100 ng/dl 9. Patient must have a life expectancy ≥ 12 months. 10. Patient must have an ECOG performance status ≤ 2. 11. 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 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. <!-- --> 1. Castration-resistant prostate cancer (CRPC). 2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy 3. Spinal cord compression or impending spinal cord compression. 4. Suspected intracranial and/or liver metastases (\>10 mm in largest axis). 5. Patient receiving any other investigational agents. 6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist. 7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR. 8. Radiographical evidence of cranial parenchymal metastasis. 9. Active second primary malignancy; AML/MDS in medical history. 10. Uncontrolled hypertension and myocardial infarction/PE/cardiac failure in last 6 months. 11. Prior treatment with PARP inhibitor 12. Refusal to sign informed consent. 13. Pathological finding consistent with small cell or neuroendocrine carcinoma of the prostate. 14. History of adrenal dysfunction 15. Long-term use of systemically administered corticosteroids (\>5mg of prednisone or the equivalent) during the study is not allowed. Short-term use (≤4 weeks, including taper) and locally administered steroids (eg, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated. 16. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: * 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: • severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, • clinically significant arterial or venous thromboembolic events (ie. Pulmonary embolism), or clinically significant ventricular arrhythmias. 18. Presence of sustained uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg). Participants with a history of hypertension are allowed, provided that blood pressure is controlled to within these limits by an antihypertensive treatment. 19. Known allergies, hypersensitivity, or intolerance to the excipients of niraparib/abiraterone acetate tablets 20. Current evidence of any medical condition that would make prednisone use contraindicated. 21. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication. 22. Participants who have had the following ≤28 days prior to randomization: • A transfusion (platelets or red blood cells); • Hematopoietic growth factors; • Major surgery 23. Human immunodeficiency virus positive participants with 1 or more of the following: • Not receiving highly active antiretroviral therapy or on antiretroviral therapy for less than 4 weeks. * 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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06212583), the sponsor (University of Maryland, Baltimore), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06212583 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06212583?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06212583?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06212583. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06212583. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.