NCT05167175

The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

Status unknown Phase 2 Last updated 25 October 2022

What this trial tests

Phase 2 trial testing Olaparib tablet in Prostate Cancer in 30 participants. Status unknown.

Timeline

1 March 2022

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Hongqian Guo
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 March 2022
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across China

Drugs / interventions tested

• Olaparib tablet — full drug profile →
• Abiraterone acetate (ABIRATERONE) — full drug profile →
• Prednisone tablet

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Prostate Carcinoma — all drugs for Prostate Carcinoma →
• Metastatic Prostate Cancer — all drugs for Metastatic Prostate Cancer →

Sponsor

Hongqian Guo — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-center, single-arm, prospective study to assess the efficacy and safety of Olaparib combined with Abiraterone plus Prednisone in subjects with metastatic hormone sensitive prostate cancer (mHSPC) who carry deleterious germline or homologous recombination repair (HRR) mutations.

Olaparib is an oral, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that potently inhibits the activity of deoxyribonucleic acid repair polymerases. Abiraterone acetate (AA) is a prodrug of abiraterone that potently inhibits cytochrome P450c17, a key enzyme in androgen biosynthesis.

A total of 30 mHSPC subjects with HRR gene mutations that meet the criteria will be included in the study. Eligible subjects will receive oral Olaparib tablets 300 mg BID, combined with Abiraterone acetate 1000 mg QD plus Prednisone 5 mg, and the study will end when the primary endpoint radiographic progression-free survival (rPFS) data maturity reaches 60%. During the treatment and follow-up periods, all subjects will have regular visits to assess the efficacy and safety of Olaparib in combination with abiraterone acetate plus prednisone. Radiographic progression-free survival (rPFS), prostate-specific antigen response (PSA response rate), prostate-specific antigen progression-free survival (PSA-PFS), radiological objective response rate (ORR) and other indicators will be assessed and calculated.

Publications & conference data

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

1. Exploring anti-androgen therapies in hormone dependent prostate cancer and new therapeutic routes for castration resistant prostate cancer.
   Harris AE, Metzler VM, Lothion-Roy J, Varun D, et al · · 2022 · cited 30× · PMID 36263323 · DOI 10.3389/fendo.2022.1006101
2. Androgen Receptor Signaling Inhibition in Advanced Castration Resistance Prostate Cancer: What Is Expected for the Near Future?
   Pozas J, Álvarez Rodríguez S, Fernández VA, Burgos J, et al · · 2022 · cited 16× · PMID 36551557 · DOI 10.3390/cancers14246071
3. Combination of PARP Inhibitors and Androgen Receptor Pathway Inhibitors in Metastatic Castration-Resistant Prostate Cancer.
   Kostos L, Tran B, Azad AA. · · 2024 · cited 11× · PMID 39060912 · DOI 10.1007/s40265-024-02071-y
4. Homologous Recombination Repair Gene Mutations in Prostate Cancer: Prevalence and Clinical Value.
   Fan Y, Liu Z, Chen Y, He Z. · · 2024 · cited 11× · PMID 38767824 · DOI 10.1007/s12325-024-02844-7
5. PARP Inhibitors in the Treatment of Prostate Cancer: From Scientific Rationale to Clinical Development.
   Kwon WA. · · 2024 · cited 11× · PMID 37853532 · DOI 10.5534/wjmh.230177
6. Use of PARP inhibitors in prostate cancer: from specific to broader application.
   Zhang Z, Diao L, Zhang C, Wang F, et al · · 2023 · cited 9× · PMID 37152924 · DOI 10.3389/fendo.2023.1164067
7. Homologous Recombination Repair Deficiency in Metastatic Prostate Cancer: New Therapeutic Opportunities.
   Piombino C, Pipitone S, Tonni E, Mastrodomenico L, et al · · 2024 · cited 7× · PMID 38731844 · DOI 10.3390/ijms25094624
8. Double trouble for prostate cancer: synergistic action of AR blockade and PARPi in non-HRR mutated patients.
   Giesen A, Baekelandt L, Devlies W, Devos G, et al · · 2023 · cited 7× · PMID 37810962 · DOI 10.3389/fonc.2023.1265812