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NCT Number: NCT06751303

Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's

Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.

We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol

Exclusion criteria

  • Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing

Treatment and study plan

Patients that are HRP are given a decision aid for PARPi use

Other

Study created patient decision aid if the first for HRD tested Ovarian Cancer patients

Primary outcomes

  1. Patient decision for use of PARPi therapy

    Time frame: 6 Monhs

    The proportion of HRP patients who choose to undergo PARP therapy.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Patient Preferences for Precision Medicine

Acronym: 4PDQ

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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