Prostate AdenocarcinomaPhase 1/2NCT04037254
Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring
A Phase 1/2 study testing Gonadotrophin Releasing Hormone, Intensity-Modulated Radiation Therapy and Niraparib in people with Prostate Adenocarcinoma and Stage IIC Prostate Cancer AJCC v8, run by NRG Oncology at 95 sites in 2 countries.
Trial summary
This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- What is being tested?
- Gonadotrophin Releasing Hormone, Intensity-Modulated Radiation Therapy and Niraparib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 95 sitesin 2 countries
- Study dates
- 8 Oct 2019to 23 Dec 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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
- Age >= 18
- 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 mmol/L (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
Who cannot join
- 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
Show all 20Show fewer
- 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)
- 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 myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- Prior or current treatment with PARP inhibitor
Trial locations and contacts
95 sites in 2 countries.
95 sites in 2 countries
United States94 sites
Summa Health System - Akron Campus
Akron, Ohio, 44304
Alton Memorial Hospital
Alton, Illinois, 62002
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Summa Health System - Barberton Campus
Barberton, Ohio, 44203
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Roswell Park Cancer Institute
Buffalo, New York, 14263
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346
Case Western Reserve University
Cleveland, Ohio, 44106
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Geisinger Medical Center
Danville, Pennsylvania, 17822
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 08234
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Singh and Arora Hematology Oncology PC
Flint, Michigan, 48532
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Self Regional Healthcare
Greenwood, South Carolina, 29646
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Mid-Michigan Physicians-Lansing
Lansing, Michigan, 48912
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Fremont - Rideout Cancer Center
Marysville, California, 95901
Summa Health Medina Medical Center
Medina, Ohio, 44256
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295
West Virginia University Healthcare
Morgantown, West Virginia, 26506
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
McLaren-Port Huron
Port Huron, Michigan, 48060
Highland Hospital
Rochester, New York, 14620
University of Rochester
Rochester, New York, 14642
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan, 48315
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Stony Brook University Medical Center
Stony Brook, New York, 11794
Holy Name Hospital
Teaneck, New Jersey, 07666
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
City of Hope Upland
Upland, California, 91786
Carle Cancer Center
Urbana, Illinois, 61801
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Canada1 site
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
About this study
Official title: Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) *Randomized Phase II Trial of Niraparib With Standard Combination Androgen DeprIvation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer (With Initial Phase I)
This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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 prostate specific antigen (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:
- 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 OBJECTIVE:
- 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 randomized 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. Patients also undergo magnetic resonance imaging (MRI) on study.
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. Patients also undergo MRI on study.
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. Patients also undergo MRI on study.
After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years.
- Conditions
- Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Being tested
- Gonadotrophin Releasing Hormone, Intensity-Modulated Radiation Therapy, Niraparib
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotrophin Releasing HormoneBiological
Also called AY-24031, D-His-6-Pro-8-NEt-LHRH, Follicle Stimulating Hormone-Releasing Factor, GN-RH
Receive standard of care GnRH agonist androgen suppression therapy
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo standard of care IMRT
NiraparibDrug
Also called MK 4827, MK-4827, MK4827
tablet
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Dose Level 1 (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. 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. Treatment is given in the absence of disease progression or unacceptable toxicity.
*Niraparib dose level 1: 100 mg. Receives: Biological: Gonadotrophin Releasing Hormone; Radiation: Intensity-Modulated Radiation Therapy; Drug: Niraparib |
| Phase I, Dose Level 2 (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. 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. Treatment is given in the absence of disease progression or unacceptable toxicity.
*Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise. Receives: Biological: Gonadotrophin Releasing Hormone; Radiation: Intensity-Modulated Radiation Therapy; Drug: Niraparib |
| Phase I, Dose Level 3 (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. 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. Treatment given in the absence of disease progression or unacceptable toxicity.
*Niraparib dose level 3: 200 mg. Receives: Biological: Gonadotrophin Releasing Hormone; Radiation: Intensity-Modulated Radiation Therapy; Drug: Niraparib |
| Phase II, Arm I (GnRH, IMRT) | Active comparator | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months. 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. Treatment is given in the absence of disease progression or unacceptable toxicity. Receives: Biological: Gonadotrophin Releasing Hormone; Radiation: Intensity-Modulated Radiation Therapy |
| Phase II, Arm II (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD (phase I determined dose level) for the first 12 months. 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. Treatment is given in the absence of disease progression or unacceptable toxicity. Receives: Biological: Gonadotrophin Releasing Hormone; Radiation: Intensity-Modulated Radiation Therapy; Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT)
Participants will be considered disease-free if their PSA values remain below 0.1 ng/ml until the completion of treatment. The proportion of patients disease-free at 24 months were to be compared in the two treatment arms using a non-continuity-corrected chi-square test. PSA levels will be assessed prior to the start of RT, at the end of RT, and every three months for 24 months. all PSA values obtained up to and including the two-year landmark must be < 0.1 ng/ml. Patients who die prior to two years from prostate cancer will be counted as failures. Patients who die from causes other than prostate cancer will be considered non-evaluable for the primary endpoint. Patients still under follow-up but who have a missing PSA value at two years or more than two missing values prior to two years will also be counted as failures.
Measured: Baseline to completion of treatment (two years from start of ADT)
Secondary outcomes (7)
Percent of Participants Alive (Overall Survival)
Survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test.
Measured: From baseline to death or last follow-up, analyzed after phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Percentage of Participants With Prostate Cancer Deaths (Prostate Cancer-specific Survival)
Prostate cancer death rates were to be estimated using the cumulative incidence method, treating deaths due to other causes as competing risks. The treatment arms were to be compared using the Fine-Gray test
Measured: From baseline to death or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Percentage of Participants With Pathologic Complete Response (pCR) at Two Years
Complete response was to be determined by a12-core biopsy. Treatment arms were to be compared using a chi-square test.
Measured: At two years
Percentage of Participants With Local/Regional or Distant Progression
Progression rates were to be estimated using the cumulative incidence method, treating deaths as competing risks. The treatment arms were to be compared using the Fine-Gray test
Measured: From baseline to local/regional or distant progression, death, or last follow-up, whichever occurs first, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Percentage of Participants With Distant Metastases
Distant metastases rates were to be estimated using the cumulative incidence method, treating death as a competing risk. The treatment arms were to be compared using the Fine-Gray test
Measured: From baseline to distant metastasis, death, or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Biochemical progression is defined as PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Biochemical progression-free survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test.
Measured: From baseline to biochemical progression or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Number of Participants by Highest Grade Adverse Event Reported
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events were to be categorized as early (within 90 days of completion of radiotherapy) or late (more than 90 days after the completion of radiotherapy).The number of participants per grade was to be compared between the arms for early, late, and all adverse events using chi-square or Fisher exact tests
Measured: From baseline to last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start8 Oct 2019
- Primary completion1 Jul 2024
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- M. D Michaelson, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037254
- Sponsor's protocol ID
- NRG-GU007
- Other IDs
- NCI-2019-02260, NRG-GU007, NRG-GU007, U10CA180868
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2019
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.