NCT03076203

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

Completed Phase 1 Last updated 29 April 2025

What this trial tests

Phase 1 trial testing Niraparib in Prostate Carcinoma Metastatic to the Bone in 14 participants. Completed in 7 November 2022.

Timeline

22 September 2017

Primary endpoint
13 January 2020

7 November 2022

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	22 September 2017
Primary completion	13 January 2020
Estimated completion	7 November 2022
Sites	6 locations across United States

Drugs / interventions tested

• Niraparib (niraparib) — full drug profile →
• Radium Ra 223 Dichloride (RADIUM RA 223 DICHLORIDE) — full drug profile →

Conditions studied

• Prostate Carcinoma Metastatic to the Bone — all drugs for Prostate Carcinoma Metastatic to the Bone →
• Stage IV Prostate Adenocarcinoma — all drugs for Stage IV Prostate Adenocarcinoma →
• Hormone-refractory Prostate Cancer — all drugs for Hormone-refractory Prostate Cancer →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

18 and older, male only, with Prostate Carcinoma Metastatic to the Bone or Stage IV Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in Prostate Cancer Treatment and Drug Discovery.
   Nevedomskaya E, Baumgart SJ, Haendler B. · · 2018 · cited 176× · PMID 29734647 · DOI 10.3390/ijms19051359
2. Overview of the Most Promising Radionuclides for Targeted Alpha Therapy: The "Hopeful Eight".
   Eychenne R, Chérel M, Haddad F, Guérard F, et al · · 2021 · cited 124× · PMID 34207408 · DOI 10.3390/pharmaceutics13060906
3. Poly-(ADP-ribose)-polymerase inhibitors as radiosensitizers: a systematic review of pre-clinical and clinical human studies.
   Lesueur P, Chevalier F, Austry JB, Waissi W, et al · · 2017 · cited 101× · PMID 28978184 · DOI 10.18632/oncotarget.19079
4. BRCA Mutations in Prostate Cancer: Prognostic and Predictive Implications.
   Messina C, Cattrini C, Soldato D, Vallome G, et al · · 2020 · cited 87× · PMID 32963528 · DOI 10.1155/2020/4986365
5. Radium-223 mechanism of action: implications for use in treatment combinations.
   Morris MJ, Corey E, Guise TA, Gulley JL, et al · · 2019 · cited 87× · PMID 31712765 · DOI 10.1038/s41585-019-0251-x
6. Genetic aberrations in DNA repair pathways: a cornerstone of precision oncology in prostate cancer.
   Lozano R, Castro E, Aragón IM, Cendón Y, et al · · 2021 · cited 81× · PMID 33106584 · DOI 10.1038/s41416-020-01114-x
7. α-Emitters for Radiotherapy: From Basic Radiochemistry to Clinical Studies-Part 2.
   Poty S, Francesconi LC, McDevitt MR, Morris MJ, et al · · 2018 · cited 70× · PMID 29496984 · DOI 10.2967/jnumed.117.204651
8. BRCA2 and Other DDR Genes in Prostate Cancer.
   Nombela P, Lozano R, Aytes A, Mateo J, et al · · 2019 · cited 68× · PMID 30871108 · DOI 10.3390/cancers11030352