Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (with Initial Phase I)

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • NRG-GU007
    NCT ID
    • NCT04037254
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Primary Objective:
    • Phase I: To establish the preferred dose of niraparib in combination with radiation and ADT
    • Phase IIR: To compare the disease-free state, defined as PSA remaining less than 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
    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
    • 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. Although the clinical benefit of niraparib in combination with radiotherapy and ADT has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to dose, safety and tolerability.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at McLaren Bay Region

    3140 W Campus Dr.
    Bay City, MI 48706
    Get Directions
    Phone: 989-667-2370

    Karmanos Cancer Institute at McLaren Clarkston

    5680 Bow Pointe Dr
    Clarkston, MI 48346
    Get Directions
    Phone: 248-922-6650

    Karmanos Cancer Institute at McLaren Flint

    4100 Beecher Rd
    Flint, MI 48532
    Get Directions
    Phone: 810-342-3800

    Karmanos Cancer Institute at McLaren Flint - Singh and Arora

    4100 Beecher Road
    Flint, MI 48532
    Get Directions

    Karmanos Cancer Institute at McLaren Greater Lansing

    1540 Lake Lansing Rd.
    Lansing, MI 48912
    Get Directions
    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Greater Lansing - Lake Lansing Road

    1540 Lake Lansing Rd.
    Lansing, MI 48912
    Get Directions
    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Lapeer Region

    1295 Barry Drive
    Lapeer, MI 48446
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at McLaren Macomb

    1080 Harrington Blvd
    Mount Clemens, MI 48043
    Get Directions
    Phone: 586-493-7500

    Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

    560 W Mitchell St
    Petoskey, MI 49770
    Get Directions
    Phone: 231-487-3390

    Karmanos Cancer Institute at McLaren Port Huron

    1221 Pine Grove Ave
    Port Huron, MI 48060
    Get Directions
    Phone: 810-982-5200