Prostate cancer trial combines four treatments to fight recurrence
NCT ID NCT04194554
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of a targeted drug (niraparib), hormone therapy, and precise radiation for men with high-risk or node-positive prostate cancer. The goal is to find the safest dose and see if this approach improves the chance of staying cancer-free for three years. About 100 men will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- niraparib (a PARP inhibitor), leuprolide (hormone blocker), abiraterone acetate (hormone blocker), and stereotactic body radiotherapy (focused radiation)
- What this could lead to
- If successful, this combination could offer a more effective treatment for high-risk prostate cancer, potentially delaying or preventing recurrence.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply to all patients. The drug combination may cause serious side effects, and it's unclear if it will improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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102 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Pathologic biopsy proven adenocarcinoma of the prostate 2. At least one of the following criteria: * cN1 on conventional or PET imaging * Grade group 5 * Grade group 4 * Grade group 3 and PSA ≥20 ng/mL * High probability of Radiographic T3 on MRI AND Grade group ≥2 * Grade Group 3 AND PSA ≥10 ng/mL AND ≥50% positive biopsy cores 3. Age ≥ 18 4. ECOG \< 1 5. Adequate organ and marrow function as defined per protocol. 6. Use of highly effective contraception (e.g. condoms) for the duration of treatment and a minimum of 120 days thereafter. Men must also agree not to donate sperm for the duration of the study participation, and for at least 120 days thereafter. 7. International Prostate Symptoms Score (IPSS) ≤ 20 8. Medically fit for treatment and agreeable to follow-up 9. Ability to understand and the willingness to sign a written informed consent 10. Tissue available for MiOncoSeq testing to assign DNA repair deficiency status Exclusion Criteria 1. Clinical or radiographic evidence of distant metastatic disease by CT/bone scan 2. Clinical or radiographic evidence of high probability of clinical T4 disease 3. Prostate gland size \>80 cc measured by ultrasound or MRI 4. Prominent median lobe assessed by treating physician 5. Lack of tissue from biopsy to be sent for correlative studies 6. Any prior treatment for prostate cancer (incudes history of TURP within 5 years of enrollment, chemotherapy, radiation therapy, or anti-androgen therapy) 7. Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies. 8. Prohibited 3 months before participant registration and during administration of study treatment: non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide), steroidal antiandrogens (megestrol acetate, cyproterone acetate), oral ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals. 9. History of prior pelvic radiation therapy 10. Concurrent treatment with strong CYP3A4 inducers such as phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital 11. Enrollment concurrently in another investigational drug study within 1 month of registration 12. History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer 13. History of or active Crohn's disease or ulcerative colitis 14. Contraindication to or inability to tolerate MRIs 15. Patients with severe depression 16. Uncontrolled diabetes or known HbA1c\>10 17. Any gastrointestinal disorder affecting absorption 18. Active pituitary or adrenal dysfunction 19. Patients with significant cardiovascular disease potentially including severe / unstable angina, recent history of myocardial infarction, clinically significant heart failure, cerebrovascular disease, venous thromboembolic events, clinically significant arrhythmias) 20. Uncontrolled hypertension with persistently elevated systolic blood pressure \>160 mmgHg or diastolic blood pressure \>100 mmHg despite anti-hypertensive agents. 21. Prolonged QTc \>450 ms or any ECG changes that interfere with QT interval interpretation 22. Major surgery within 1 month of registration 23. History of myelodysplastic syndrome or leukemia 24. A known hypersensitivity to niraparib, abiraterone acetate, leuprolide, and/or prednisone 25. Active infection or other medical condition that would be a contraindication to prednisone use 26. Patients with known active hepatitis or chronic liver disease including cirrhosis 27. Any condition that in the opinion of the investigator would preclude participation in this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cornell University
New York, New York, 10065, United States
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Mayo Clinic
Rochester, Minnesota, 55901, United States
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University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106, United States
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
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University of Texas Southwestern
Dallas, Texas, 75390, United States
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Weill Cornell Medicine
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?