Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03076203
Phase
PHASE1
Status
Completed

Conditions

  • Hormone-refractory Prostate Cancer
  • Prostate Carcinoma Metastatic to the Bone
  • Stage IV Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Given orally
  • Radium Ra 223 Dichloride — RADIATION
    Given intravenously

Study Details

This phase Ib trial studies the side effects and best dose of niraparib when given together with radium Ra223 dichloride in treating subjects with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels and has spread from the primary site to the bone. Radium Ra 223 dichloride, acts like calcium to target cancer in the bones and may deliver radiation directly to the bone tumors, limiting damage to the surrounding normal tissue. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radium Ra 223 dichloride and niraparib may work better in treating subjects with hormone-resistant prostate cancer metastatic to the bone.

Key Dates

Start date
Sep 22, 2017
Status verified
Apr 2025
Primary completion
Jan 13, 2020
Completion
Nov 7, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (niraparib, radium Ra 223 dichloride)
    Patients receive niraparib orally daily and radium Ra 223 dichloride IV over 1 minute every 4 weeks. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose of niraparib to combine with radium Ra 223 dichloride based on dose limiting toxicities graded by National Cancer Institute, Common Toxicity Criteria, version 4.0 [ Time Frame: 12 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35249-
University of Chicago Medical CenterChicagoIllinois60637-
Tulane UniversityNew OrleansLouisiana70112-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALUniversity of Chicago Medical Center· Chicago, ILTulane University· New Orleans, LABeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MASidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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