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

NCT06751303 | Recruiting DMC

• 1 other identifier: 4118
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Quality of Life

Keywords

PARPi; HRD testing

Outcome Measures

Primary Outcomes (1)

• Patient decision for use of PARPi therapy

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

  6 Monhs

Study Arms (1)

HRD Tested

OTHER

HRP patients are given a decision aid, while HRD patients are not given a decision.

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

Interventions

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

HRD Tested

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatchewan Cancer Center

Saskatoon, S, S7V4H4, Canada

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology

Model Details: This is a pragmatic trial which offers HRD testing and for patients HRProficient, a patient decision aid to help them decide whether niraparib is right for them. Whatever they decide, we followup with QoL questionnaires and assessment of time to progression.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: September 17, 2023
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 16, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)