Table 3.
Rucaparib’s Ongoing Clinical Trials for Prostate Cancer
Clinicaltrials.Gov Identification Number and Name (if Applicable) | Phase of and Type of Clinical Trial | Condition Treated and Details (if Applicable) | Mutations tested (if Applicable) | Interventions Tested (Arms) | Start Date | Projected Primary Completion Date |
---|---|---|---|---|---|---|
TRITON3, NCT02975934 | Phase III, multi-arm, open-label | mCRPC, with previous next generation ARAT | BRCA1/2 or ATM | Rucaparib vs Abiraterone or Enzalutamide or Docetaxel | June 2017 | June 2022 (no results posted as of July 2022) |
PLATI-PARP, NCT03442556 | Phase II, single-arm, open-label | mCRPC, with some prior therapy as long as it does not include a PARP inhibitor or platinum chemotherapy | Any pathogenic or inactivating alteration in a gene associated with HRR | Induction Carboplatin and Docetaxel followed by maintenance with Rucaparib | August 2018 | May 2025 |
TRIUMPH, NCT03413995 | Phase II, single-arm, open-label | mHSPC, without prior ADT treatment (either ineligible for or declined ADT therapy). The trial would provide an alternative to ADT | Germline mutation in one or more of the following HRR genes (BRCA1/2, ATM, CHEK2, NBN, RAD50, RAD51C, RAD51D, PALB2, MRE11, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM) | Rucaparib | September 2018 | December 2022 |
ROAR, NCT03533946 | Phase II, single-arm, open-label | nmHSPC | Mutation in one of the following HRR-associated genes (BARD1, BRCA1/2, BRIP1, CHEK1, CHEK2, FANCA, NBN, PALB2, RAD51C, RAD51D, RAD51, RAD51B) | Rucaparib | May 2019 | July 2023 |
LODESTAR, NCT04171700 | Phase II, single-arm, open-label | Any solid tumor | Somatic or germline deleterious mutation in a HRR gene (BRCA1/2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B) | Rucaparib | November 2019 | May 2022 |
RAMP, NCT04179396 | Phase Ib, multi-arm, open-label | mCRPC, with or without previous ARAT | N/A | Rucaparib and enzalutamide vs Rucaparib and abiraterone | December 2019 | November 2022 |
BrUOG 360, NCT04253262 | Phase Ib/II, single-arm with multiple dose measurements, open-label | mCRPC, with previous abiraterone, enzalutamide, and/or aplutamide therapy | N/A | Rucaparib and Copanlisib together with varying doses of both – objective is to find maximal tolerable dose to then test in Phase II part of study | April 2020 | July 2021 (no results posted as of July 2022) |
CASPAR, NCT04455750 | Phase III, multi-arm, double-blinded | mCRPC, with no prior therapy for mCRPC at the time of registration, meaning that the patient had not had major surgery or radiation for ≥4 weeks, had not been on investigational therapy for ≥4 weeks or 5 half-lives (the shorter period), and had not been on flutamide, dutasteride, bicalutamide, niltamide, finasteride, aminoglutethimide, estrogens, cytoproterone, chemotherapy, abiraterone, apalutamide, or darolutamide for ≥4 weeks or 5 half-lives (the shorter period). Moreover, prior docetaxel and/or ARAT was allowed only if for nmHSPC, mHSPC, or nmCRPC. No prior therapy with enzalutamide, PARP inhitors, or platinum chemotherapy was allowed. | N/A | Enzalutamide and Rucaparib vs Enzalutamide and Placebo If patient has not undergone bilateral orchiectomy ADT is included (both arms) |
February 2021 | May 2023 |
CATCH-R, NCT04676334 | Phase III, single-arm, open-label (maintenance therapy for patients currently benefitting from rucaparib) | mCRPC, ovarian cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, other solid tumor | N/A | Rucaparib | March 2021 | November 2023 |
Note: Data from Wei et al.57
Abbreviations: mCRPC, metastatic castrate-resistant prostate cancer; ARAT, androgen receptor-axis-targeted therapies; PARP, poly(adenosine diphosphate-ribose) polymerase; HRR, homologous recombination repair; mHSPC, metastatic hormone sensitive prostate cancer; ADT, androgen deprivation therapy; nmHSPC, non-metastatic hormone sensitive prostate cancer; nmCRPC, non-metastatic castration-resistant prostate cancer.