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Prostate CancerPhase 2PROspectNCT05262608

The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation

A Phase 2 study testing Olaparib in people with Prostate Cancer and Prostate Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 multi-center, single-arm, prospective study to assess the efficacy and safety of Olaparib in men with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) who carried homologous recombination repair (HRR) gene mutations and have progressed after treatment with novel endocrine agents (NHA)… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Olaparib
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
7 Dec 2021to 26 Apr 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 0-2.
  • Histologically confirmed adenocarcinoma of the prostate.
  • Subjects must have previously received NHA (e.g., abiraterone acetate and/or enzalutamide) for mHSPC or nmCRPC and have disease progression to mCRPC. Disease progression was determined by the local investigator based on the diagnostic criteria for mCRPC (CRPC diagnostic criteria: testosterone maintained at castrate levels (testosterone levels less than 50 ng/dL or 1.7 nmol/L) while meeting at least one of the following criteria: A. biochemical progression: three consecutive rising PSA with an interval of at least one week between the two tests, more than 50% increase from the nadir, and PSA > 2 ng/mL; B. radiographic progression: new lesions: two or more new bone lesions on bone scan or one soft tissue lesion meeting the RECIST criteria. Symptomatic progression alone is not sufficient to diagnose CRPC. Established radiographic evidence of metastatic disease in addition to CRPC to confirm the diagnosis of mCRPC).
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  • 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 at least 1 measurable lesion at baseline (according to RECIST 1.1 criteria: At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements).
  • Subjects must have at least 1 qualifying HRR gene mutation in tumor tissue and/or plasma ct-DNA confirmed by central lab (Glorious Med, shanghai, China)
  • 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.
  • Subjects must have normal organ and bone marrow function at baseline, as defined below:
  • Hemoglobin ≥ 10.0 g/dL without previous transfusion.
  • 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 subject has been surgically sterilized or uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 12 weeks after the dose of prednisone.
  • 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 including Olaparib.
  • 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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  • Other malignancies within the last 5 years.
  • 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) 3 weeks prior to study treatment.
  • Medications used to maintain castrate status were 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, or carbidetex-boosted protease inhibitors, indinavir, saquinavir, nelfinavir, baprevir, teicoplanavir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, sulfadiazine, fluconazole, vilapamil) requires a 2-week washout period prior to initiation of Olaparib therapy.
  • Concomitant use of strong CYP3A inducers (e.g. phenobarbital, empagliflozin, phenytoin, rifampin, rifampin, rifampin, rifapentine, carbamazepine, nevirapine, and Forsythia leaf) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). If co-administered with phenobarbital, 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 hypersensitivity to Olaparib or any of the excipients of this product.
  • 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, 12 myocardial infarction, 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.

Hao Liu contact

+86-13560338664

liuh65@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

    Hao Liu, 86-13560338664, liuh65@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Monotherapy in Newly Diagnosed mCRPC Patients Who Progressed on NHA and With HRR Gene Mutation

This is a multi-center, single-arm, prospective study to assess the efficacy and safety of Olaparib in men with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) who carried homologous recombination repair (HRR) gene mutations and have progressed after treatment with novel endocrine agents (NHA) in the metastatic castration-sensitive prostate cancer or non-metastatic castration-resistant prostate cancer.

A total of 30 newly diagnosed mCRPC subjects with radiologically evaluable disease at baseline who have progressed on prior NHA and carry HRR gene mutations that meet the criteria will be included in the study. Eligible subjects will receive a treatment regimen of oral Olaparib tablets 300 mg twice daily until disease progression or intolerance. During the treatment and follow-up periods, all subjects will have regular visits to assess the efficacy and safety of Olaparib. Data on objective radiographic response (ORR), prostate-specific antigen response (PSA response), radiographic progression-free survival (rPFS), and time to prostate-specific antigen progression (TTPP) will be collected during the study.

Being tested
Olaparib
Keywords
HRR, Olaparib, mCRPC
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • OlaparibDrug

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

Study groups in NCT05262608
Study groupRoleWhat they receive
Intervention/TreatmentExperimentalSubjects will receive a regimen of Olaparib tablets 300 mg twice daily until radiographic disease progression (assessed by the investigator according to RECIST1.1 and PCWG 3) or intolerable adverse events (assessed by the investigator according to the actual clinical situation).
Receives: Drug: Olaparib

What is being measured

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

  1. Primary Outcome Measures 1

    1. To assess the efficacy of Olaparib in newly diagnosed metastatic castration-resistant prostate cancer with mutations in homologous recombination repair genes that have progressed after prior treatment with novel endocrine agents.

    -The Overall response rate will be based on the following outcome definitions and a patient will be considered a response if any of these occur:

    (1) Objective response (ORR) according to RECIST 1.1 (soft tissue)

    Measured: up to 60 months

  2. Primary Outcome Measures 2

    Objective response (ORR) according to PCWG-3 (bone) criteria as determined by the local investigator

    Measured: up to 60 months

  3. Primary Outcome Measures 3

    PSA response will be reported in ng/mL (≥ 50% reduction in PSA from baseline) according to PCWG 3 criteria as determined by the local investigator

    Measured: up to 60 months

Secondary outcomes (4)

  1. Secondary Outcome Measures 1

    Investigator-assessed confirmed radiographic progression-free survival (rPFS) will be reported in weeks per RECIST 1.1 (soft tissue) and PCWG3 (bone)

    Measured: up to 60 months

  2. Secondary Outcome Measures 2

    Investigator-assessed confirmed disease control rate (DCR) per RECIST 1.1 (soft tissue) and PCWG3 (bone)

    Measured: up to 60 months

  3. Secondary Outcome Measures 3

    Investigator-assessed confirmed the time to PSA progression (TTPP) per PCWG3

    Measured: up to 60 months

  4. Secondary Outcome Measures 3

    1. To assess the safety and tolerability of Olaparib in newly diagnosed metastatic castration-resistant prostate cancer with homologous recombination repair gene mutations that have progressed after prior treatment with novel endocrine agent.

    -Adverse events/Serious adverse events/AE of special interest

    Measured: up to 60 months

Timeline

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

  1. First posted2 Mar 2022
  2. Study start7 Dec 2021
  3. Primary completion26 Feb 2024 (estimated)
  4. Study completion26 Apr 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
NCT05262608
Sponsor's protocol ID
2021-KY-057
Acronym
PROspect
Status last verified
Feb 2022
First submitted
8 Feb 2022
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib in people with Prostate Cancer and Prostate Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 22 inclusion and 24 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 2 Mar 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?

Contact Hao Liu (+86-13560338664, liuh65@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measures 1 (time frame: up to 60 months). The study lists 3 primary outcomes in all. 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 NCT05262608.

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 2 Mar 2022.

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