Niraparib + Standard Therapy for Prostate Cancer

(NADIR Trial)

Recruiting at96 trial locations

Overseen by M. D Michaelson

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a phase I-II trial to find the safety and activity of adding a new drug (neratinib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding niraparib to the usual care may lower the chance of prostate cancer growing or returning.

Research Team

M. D Michaelson

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for men with high-risk prostate cancer that hasn't spread elsewhere. Eligible participants have a Gleason score of 7 or higher, PSA levels below certain thresholds, and good organ function. They must not have had prior treatments like radical prostatectomy or systemic therapy for prostate cancer and should be willing to use contraception.

Inclusion Criteria

Gleason 8, PSA < 20 ng/mL, and ≥ T2

Hemoglobin ≥ 9.0 g/dL (within 90 days prior to registration)

Serum total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ 1 x ULN (Note: in subjects with Gilberts syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (within 90 days prior to registration)

Exclusion Criteria

PSA > 150 ng/mL

Definitive clinical or radiologic evidence of metastatic disease

Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging

Treatment Details

Interventions

• Gonadotrophin Releasing Hormone (Hormone Therapy)
• Intensity-Modulated Radiation Therapy (Radiation)
• Niraparib (PARP Inhibitor)

Trial Overview The study tests the effectiveness of Niraparib (an enzyme blocker) combined with standard radiation and hormonal therapies in preventing the return of high-risk prostate cancer. It's a phase II trial aiming to find the best dose while monitoring side effects.

Participant Groups

Group I: Phase II, Arm II (niraparib, GnRH, IMRT) Experimental Treatment 3 Interventions

Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.

Group II: Phase I (niraparib, GnRH, IMRT) Experimental Treatment 4 Interventions

Patients receive niraparib PO QD and receive standard of care GnRH agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.

Group III: Phase II, Arm I (GnRH, IMRT) Active Control 3 Interventions

Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School