Prostate Cancer Clinical Trial

Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer

Summary

This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To establish the preferred dose of niraparib in combination with radiation and antiandrogen therapy (ADT). (Phase I) II. To compare the disease-free state, defined as PSA remaining < 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib. (Phase IIR)

SECONDARY OBJECTIVES:

I. To further establish the safety and toxicity profile of standard treatment with radiation and androgen deprivation therapy specifically, two years from initiation of ADT, plus niraparib at the phase II dose.

II. To compare the overall survival, prostate cancer-specific survival, local/regional or distant progression, and distant metastatic disease rates of standard therapy with or without the addition of niraparib.

EXPLORATORY OBJECTIVES:

I. To identify genomic biomarkers of response to combination therapy with radiation, ADT and PARP inhibition.

OUTLINE: This is a phase I, dose-escalation study of niraparib, followed by a phase II study.

PHASE I: Patients receive niraparib orally (PO) once daily (QD) and receive standard of care gonadotrophin releasing hormone (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 intensity-modulated radiation therapy (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.

PHASE II: Patients are randomized to 1 of 2 arms:

ARM I: 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.

ARM II: 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.

After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed (within 180 days prior to registration) adenocarcinoma of the prostate at high risk for recurrence as determined by the following criteria, according to American Joint Committee on Cancer (AJCC) 8th edition:

Phase I enrollment

Gleason >= 9, PSA =< 150 ng/mL, any T-stage

Phase II enrollment

Gleason >= 9, PSA =< 150 ng/mL, any T-stage
Gleason 8, PSA < 20 ng/mL, and >= T2
Gleason 8, PSA >= 20-150 ng/mL, any T-stage
Gleason 7, PSA >= 20-150 ng/mL, any T-stage

No distant metastases as evaluated by:

Bone scan 90 days prior to registration
Lymph node assessment by computed tomography (CT) or magnetic resonance (MR) of pelvis or nodal sampling within 90 days prior to registration (Please note: Lymph nodes will be considered negative (N0) if they are < 1.5 cm short axis)
History/physical examination within 90 days prior to registration
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 180 days prior to registration
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Phase I patients: Prior androgen suppression for prostate cancer is not allowed prior to registration
Phase II patients: Prior androgen suppression for prostate cancer is allowed =< 45 days prior to registration
Hemoglobin >= 9.0 g/dL (within 90 days prior to registration)
Platelets >= 100,000 cells/mm^3 (within 90 days prior to registration)
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 90 days prior to registration)
Serum creatinine =<1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance >= 30 mL/min estimated using Cockcroft-Gault equation (within 90 days prior to registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN (within 90 days prior to registration)
Serum albumin >= 3 g/dL (within 90 days prior to registration)
Serum potassium >= 3.5 mg/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)
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

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
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Any active malignancy within 2 years of study registration that may alter the course of prostate cancer treatment.
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields
Current treatment with first generation anti-androgens (bicalutamide, nilutamide, flutamide). For patients enrolled to phase II, if prior anti-androgens were administered, a washout period of >= 30 days is required prior to enrollment

Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Uncontrolled acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition
Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >=160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment
Prior allergic reaction to the drugs involved in this protocol (including known allergies, hypersensitivity or intolerance to the excipients of niraparib. Please see Niraparib IB for details.)

Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter

Note that patients who are HIV positive are eligible, provided they have a CD4 count >= 200 cells/microliter within 90 days prior to registration. Patients receiving treatment with highly active antiretroviral therapy (HAART) will not be eligible due to concern for radiosensitization
Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be affected by these drugs.
Any history or current diagnosis of Myelodysplasitc Syndromes (MDS)/ Acute Myeloid Leukemia (AML).
Prior or current treatment with PARP inhibitor

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT04037254

Recruitment Status:

Recruiting

Sponsor:

NRG Oncology

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There are 86 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Site Public Contact
Contact
602-747-9738
Isaac A. Bowman
Principal Investigator
University of Arizona Cancer Center-Orange Grove Campus
Tucson Arizona, 85704, United States
University of Arizona Cancer Center-North Campus
Tucson Arizona, 85719, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States More Info
Site Public Contact
Contact
310-423-8965
Zachary S. Zumsteg
Principal Investigator
Fremont - Rideout Cancer Center
Marysville California, 95901, United States More Info
Site Public Contact
Contact
530-749-4400
Richard K. Valicenti
Principal Investigator
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Site Public Contact
Contact
916-734-3089
Richard K. Valicenti
Principal Investigator
City of Hope Upland
Upland California, 91786, United States
George Washington University Medical Center
Washington District of Columbia, 20037, United States More Info
Site Public Contact
Contact
202-741-2981
Yuan J. Rao
Principal Investigator
Grady Health System
Atlanta Georgia, 30303, United States More Info
Site Public Contact
Contact
404-489-9164
Ashesh B. Jani
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Site Public Contact
Contact
404-778-1868
Ashesh B. Jani
Principal Investigator
Emory Saint Joseph's Hospital
Atlanta Georgia, 30342, United States More Info
Site Public Contact
Contact
404-851-7115
Ashesh B. Jani
Principal Investigator
CTCA at Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
Northwestern University
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
312-695-1301
[email protected]
Sean Sachdev
Principal Investigator
Rush University Medical Center
Chicago Illinois, 60612, United States More Info
Site Public Contact
Contact
312-942-5498
[email protected]
Dian Wang
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Vamsi K. Vasireddy
Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States More Info
Site Public Contact
Contact
800-237-1225
Joseph M. Caster
Principal Investigator
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Xinglei Shen
Principal Investigator
University of Kansas Cancer Center-Overland Park
Overland Park Kansas, 66210, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Xinglei Shen
Principal Investigator
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Xinglei Shen
Principal Investigator
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States More Info
Site Public Contact
Contact
800-888-8823
Young Kwok
Principal Investigator
Central Maryland Radiation Oncology in Howard County
Columbia Maryland, 21044, United States More Info
Site Public Contact
Contact
443-546-1300
Young Kwok
Principal Investigator
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie Maryland, 21061, United States More Info
Site Public Contact
Contact
410-553-8100
Young Kwok
Principal Investigator
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States More Info
Site Public Contact
Contact
877-726-5130
M. D. Michaelson
Principal Investigator
McLaren Cancer Institute-Bay City
Bay City Michigan, 48706, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Henry Ford Cancer Institute-Downriver
Brownstown Michigan, 48183, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Eleanor M. Walker
Principal Investigator
McLaren Cancer Institute-Clarkston
Clarkston Michigan, 48346, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Henry Ford Macomb Hospital-Clinton Township
Clinton Township Michigan, 48038, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Eleanor M. Walker
Principal Investigator
Henry Ford Medical Center-Fairlane
Dearborn Michigan, 48126, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Eleanor M. Walker
Principal Investigator
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Eleanor M. Walker
Principal Investigator
Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
McLaren Cancer Institute-Flint
Flint Michigan, 48532, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Singh and Arora Hematology Oncology PC
Flint Michigan, 48532, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing Michigan, 48910, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Mid-Michigan Physicians-Lansing
Lansing Michigan, 48912, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
McLaren Cancer Institute-Lapeer Region
Lapeer Michigan, 48446, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
McLaren Cancer Institute-Macomb
Mount Clemens Michigan, 48043, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Henry Ford Medical Center-Columbus
Novi Michigan, 48377, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Eleanor M. Walker
Principal Investigator
McLaren Cancer Institute-Northern Michigan
Petoskey Michigan, 49770, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
McLaren-Port Huron
Port Huron Michigan, 48060, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Brian K. Yeh
Principal Investigator
Henry Ford Macomb Health Center - Shelby Township
Shelby Michigan, 48315, United States
Henry Ford West Bloomfield Hospital
West Bloomfield Michigan, 48322, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Eleanor M. Walker
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
Site Public Contact
Contact
601-815-6700
John C. Henegan
Principal Investigator
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Brian C. Baumann
Principal Investigator
University of Kansas Cancer Center - North
Kansas City Missouri, 64154, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Xinglei Shen
Principal Investigator
University of Kansas Cancer Center - Lee's Summit
Lee's Summit Missouri, 64064, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Xinglei Shen
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Brian C. Baumann
Principal Investigator
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Brian C. Baumann
Principal Investigator
Siteman Cancer Center at Saint Peters Hospital
Saint Peters Missouri, 63376, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Brian C. Baumann
Principal Investigator
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
AtlantiCare Health Park-Cape May Court House
Cape May Court House New Jersey, 08210, United States
AtlantiCare Surgery Center
Egg Harbor Township New Jersey, 08234, United States
Rutgers New Jersey Medical School
Newark New Jersey, 07101, United States More Info
Site Public Contact
Contact
732-235-7356
Malcolm D. Mattes
Principal Investigator
Holy Name Hospital
Teaneck New Jersey, 07666, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Site Public Contact
Contact
800-767-9355
[email protected]
Michael R. Kuettel
Principal Investigator
The New York Hospital Medical Center of Queens
Flushing New York, 11355, United States
Highland Hospital
Rochester New York, 14620, United States More Info
Site Public Contact
Contact
585-341-8113
Paul M. Barr
Principal Investigator
University of Rochester
Rochester New York, 14642, United States More Info
Site Public Contact
Contact
585-275-5830
Paul M. Barr
Principal Investigator
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
Summa Health System - Akron Campus
Akron Ohio, 44304, United States More Info
Site Public Contact
Contact
330-375-4221
[email protected]
Bradley T. Clifford
Principal Investigator
Summa Health System - Barberton Campus
Barberton Ohio, 44203, United States More Info
Site Public Contact
Contact
330-375-4221
[email protected]
Bradley T. Clifford
Principal Investigator
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States More Info
Site Public Contact
Contact
513-584-7698
[email protected]
Timothy D. Struve
Principal Investigator
Case Western Reserve University
Cleveland Ohio, 44106, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Daniel E. Spratt
Principal Investigator
University of Cincinnati Cancer Center-West Chester
West Chester Ohio, 45069, United States More Info
Site Public Contact
Contact
513-584-7698
[email protected]
Timothy D. Struve
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Tyler Gunter
Principal Investigator
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Site Public Contact
Contact
570-271-5251
[email protected]
Namita Sharma
Principal Investigator
Geisinger Medical Oncology-Lewisburg
Lewisburg Pennsylvania, 17837, United States More Info
Site Public Contact
Contact
570-374-8555
[email protected]
Namita Sharma
Principal Investigator
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States More Info
Site Public Contact
Contact
717-242-7703
[email protected]
Namita Sharma
Principal Investigator
Eastern Regional Medical Center
Philadelphia Pennsylvania, 19124, United States
UPMC-Shadyside Hospital
Pittsburgh Pennsylvania, 15232, United States More Info
Site Public Contact
Contact
412-621-2334
Adam Olson
Principal Investigator
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States More Info
Site Public Contact
Contact
570-271-5251
[email protected]
Namita Sharma
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Emory McTyre
Principal Investigator
Saint Francis Cancer Center
Greenville South Carolina, 29607, United States More Info
Site Public Contact
Contact
864-603-6213
[email protected]
Robert D. Siegel
Principal Investigator
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States More Info
Site Public Contact
Contact
864-241-6251
Emory McTyre
Principal Investigator
Self Regional Healthcare
Greenwood South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States More Info
Site Public Contact
Contact
864-241-6251
Emory McTyre
Principal Investigator
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
West Virginia University Healthcare
Morgantown West Virginia, 26506, United States More Info
Site Public Contact
Contact
304-293-7374
[email protected]
Amir Kamran
Principal Investigator
Froedtert Menomonee Falls Hospital
Menomonee Falls Wisconsin, 53051, United States More Info
Site Public Contact
Contact
262-257-5100
Colleen A. Lawton
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-805-3666
Colleen A. Lawton
Principal Investigator
Zablocki Veterans Administration Medical Center
Milwaukee Wisconsin, 53295, United States More Info
Site Public Contact
Contact
888-469-6614
Elizabeth M. Gore
Principal Investigator
Drexel Town Square Health Center
Oak Creek Wisconsin, 53154, United States More Info
Site Public Contact
Contact
414-805-0505
Colleen A. Lawton
Principal Investigator
ProHealth Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States More Info
Site Public Contact
Contact
262-928-7878
Timothy R. Wassenaar
Principal Investigator
UW Cancer Center at ProHealth Care
Waukesha Wisconsin, 53188, United States More Info
Site Public Contact
Contact
262-928-5539
[email protected]
Timothy R. Wassenaar
Principal Investigator
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend Wisconsin, 53095, United States More Info
Site Public Contact
Contact
414-805-0505
Colleen A. Lawton
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT04037254

Recruitment Status:

Recruiting

Sponsor:


NRG Oncology

How clear is this clinincal trial information?

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