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RECRUITING
NCT06751303
NA

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

Sponsor: University of Saskatchewan

View on ClinicalTrials.gov

Summary

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.

Official title: Patient Preferences for Precision Medicine

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-09-17

Completion Date

2027-09-16

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

OTHER

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

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

Locations (1)

Saskatchewan Cancer Center

Saskatoon, S, Canada