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Prostate CancerPhase 2NCT05167175

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

A Phase 2 study testing Olaparib tablet, Abiraterone acetate and Prednisone tablet in people with Prostate Cancer and Prostate Carcinoma, run by Hongqian Guo at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Olaparib tablet, Abiraterone acetate and Prednisone tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Mar 2022to 1 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For inclusion in the study, subjects should fulfil the following criteria based on local regulations:
  • Provision of informed consent prior to any study specific procedures.
  • Adult male patients (age≥18 years old).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Subjects must have at least 1 qualifying HRR gene mutation in tumor tissue by central lab (Glorious Med, shanghai, China).
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  • Archival or new biopsies are acceptable.
  • Qualifying HRR gene mutations (deleterious or suspected deleterious gene alterations) are BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD 51C, RAD51D and RAD54L mutations confirmed by the central lab.
  • The subject had a serum testosterone level ≤ 50 ng/dL (≤ 1.75 nmol/L) before enrollment.
  • Patients who have not undergone previous surgery must be taking and voluntarily continue taking LHRH analogues (agonists or antagonists) throughout the study treatment period.
  • Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 10.0 g/dL without previous transfusion within 28 days.
  • Absolute neutrophil count ≥ 1.5 × 10^9/L.
  • Platelet count ≥ 100 × 10^9/L.
  • Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified.
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 2.5 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.
  • Estimated creatinine clearance ≥ 51 mL/min (estimated creatinine clearance = [140 - age (years)] × weight (kg)/(serum creatinine (mg/dL)×72)).
  • Male patients must use a condom during treatment and for 12 weeks after the last dose of Olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception ([see appendix C for acceptable methods]) if they are of childbearing potential
  • Subjects must have a life expectancy ≥ 16 weeks.
  • The subjects must volunteer and be capable of complying with the protocol for the duration of the study, including receiving treatment, attending scheduled visits and hospital examinations.

Who cannot join

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) .
  • Previous enrolment in the present study.
  • Subjects participated in another clinical study with a drug or plan to participate in another interventional clinical study within 30 days prior to enrollment.
  • Prior treatment with any PARP inhibitor or any new hormone agent, including Olaparib, Niraparib, Abiraterone, Enzalutamide, Apalutamide, etc.
  • Prior chemotherapy with any DNA-damaging cytotoxic agent unless used to treat non-prostate cancer and the last dose was at least 5 years prior to enrollment in this study. For example: Patients previously treated with mitoxantrone or platinum-based chemotherapy for prostate cancer are excluded.
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  • Patients who have received prior chemotherapy with any taxane. For example, patients who have received prior Docetaxel for prostate cancer are excluded.
  • Other malignancies within the last 5 years.
  • History of adrenal dysfunction.
  • Presence of persistent uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg). Subjects with a history of hypertension are allowed to participate if blood pressure could be controlled within these limits by antihypertensive therapy.
  • Uncontrolled or underlying cardiac disease on resting electrocardiogram (eg, but not limited to: unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QT prolongation > 500 ms with Fridericia correction, congenital long QT syndrome).
  • The subject had received any systemic anticancer therapy (except radiotherapy for palliative reasons) 3 weeks prior to study treatment.
  • Medications used to maintain castrate status are permitted as described in Inclusion Criteria 7. Drugs such as 5-α reductase inhibitors (finasteride, dutasteride), estrogen compounds and megestrol are considered as anticancer drugs and are prohibited at least 3 weeks before study treatment.
  • Treatment of bone metastases with denosumab or bisphosphonates such as zoledronic acid is allowed.
  • Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, ritonavir, cobicistat, boceprevir or carbidetex-boosted protease inhibitors, indinavir, saquinavir, nelfinavir, baprevir, teicoplanavir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, sulfadiazine, fluconazole, diltiazem, vilapamil) requires a 2-week washout period prior to initiation of Olaparib therapy.
  • Concomitant use of strong CYP3A inducers (e.g. phenobarbital, empagliflozin, enzalutamide, phenytoin, rifampin, rifapentine, rifabutin, carbamazepine, nevirapine, and Forsythia leaf) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). If co-administered with phenobarbital or enzalutamide, a 5-week washout period is required before the start of Olaparib therapy and a 3-week washout period is required when co-administered with other drugs.
  • Subjects with major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  • Subjects with previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Long-term toxicity (CTCAE > grade 2) due to prior cancer therapy, excluding toxicity due to alopecia or use of LHRH agonists or antagonists.
  • Subjects with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML
  • Subjects with known brain metastases (confirmation of absence of brain metastases by scan is not required).
  • Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 4 weeks.
  • Subjects who are unable to swallow oral medication and/or have a gastrointestinal disorder that would interfere with absorption of the study drug.
  • Subjects with known allergic to Olaparib or Abiraterone acetate or any of the excipients of the two products.
  • Immunocompromised subjects, such as those with positive human immunodeficiency virus (HIV) serology.
  • Subjects with known active hepatitis (e.g. hepatitis B or C).
  • The subject has a serious, uncontrolled medical condition or non-malignant systemic disease, or an uncontrolled active infection. ( For example, but not limited to: uncontrolled arrhythmia, uncontrolled (with 12 weeks) myocardial infarction, unstable spinal cord compression, superior vena cava syndrome, uncontrolled seizures, extensive interstitial lung disease in both lungs, or psychiatric disease that would preclude informed consent.)

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

    Nanjing, Jiangsu, 210008

    Junlong Zhuang, MD, 8615950451917, zhuangjl-2008@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

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.

Being tested
Olaparib tablet, Abiraterone acetate, Prednisone tablet
Keywords
HRR, Olaparib, mCSPC
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olaparib tabletDrug

    Also called Lynparza

    Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily.

  • Abiraterone acetateDrug

    Also called Qingkeshu

    Qingkeshu (Abiraterone acetate tablets) 1000 mg should be taken orally once daily.

  • Prednisone tabletDrug

    Prednisone Tablets should be taken 5 mg once daily.

Study groups in NCT05167175
Study groupRoleWhat they receive
Intervention/TreatmentExperimentalSubjects will receive a regimen of Olaparib tablets 300 mg twice daily in combination with Abiraterone acetate 1000 mg plus Prednisone 5mg once daily until radiographic disease progression (assessed by the investigator according to RECIST1.1 and PCWG3) or intolerable adverse events (assessed by the investigator according to the actual clinical situation).
Receives: Drug: Olaparib tablet; Drug: Abiraterone acetate; Drug: Prednisone tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-Free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator

    Time from the start of study drug to radiographic progression, or death due to any cause, whichever occurs first.

    Measured: 18 month

Secondary outcomes (3)

  1. PSA response rate

    PSA response is defined as a ≥ 50% decline in PSA from baseline PSA value. This PSA decline must be confirmed as sustained by a second PSA value obtained ≥ 3 weeks later.

    Measured: 18 month

  2. PSA Progression Free Survival (PSA-PFS) by Investigator

    PSA-PFS is defined as the time from the start of study drug to the first PSA progression or death due to any cause without progression. PSA progression is defined as a first PSA increase greater than or equal to 25% of baseline and ≥ 2 ng/ml and confirmed a second time after 3 or more weeks.

    Measured: 18 month

  3. Confirmed Objective Response Rate (ORR) by Investigator

    ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.

    Measured: 18 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start1 Mar 2022
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167175
Sponsor's protocol ID
PROact
Status last verified
Oct 2022
First submitted
13 Jul 2021
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang X, Wu Z, Hao L, Qiu X, Xu L, Zhang S, Guo H, Zhuang J. Olaparib combined with abiraterone in HRR-mutated metastatic hormone-sensitive prostate cancer: a single-arm phase II trial. World J Urol. 2026 May 11;44(1):354. doi: 10.1007/s00345-026-06460-8.

    PubMed 42115448

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib tablet, Abiraterone acetate and Prednisone tablet in people with Prostate Cancer and Prostate Carcinoma, run by Hongqian Guo at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator (time frame: 18 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05167175, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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