RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Relugolix
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 110
- Locations
- 3
- Primary Endpoint
- 9-month Quality of Life (QOL) Score
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label.
The names of the study drugs involved in this study are:
- Leuprolide (type of ADT)
- Relugolix (type of ADT)
Detailed Description
This is a phase 2 clinical trial comparing patient-reported Quality of Life (QOL) among men with localized or biochemically recurrent prostate cancer treated with relugolix versus leuprolide depot therapy. Participants will be randomized into one of the study groups leuprolide versus relugolix. Randomization means that a participant is put into a study group by chance. The U.S. Food and Drug Administration (FDA) has approved leuprolide and relugolix as treatment options for prostate cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, ECGs, and blood tests. Participation in this research study is expected to last 12 months. It is expected about 110 people will take part in this research study. The Prostate Cancer Foundation and Pfizer are supporting this research study by providing funding. Myovant is supporting this study by providing the drug, Relugolix.
Investigators
Alicia Morgans
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Participants must have a histologic diagnosis of prostate adenocarcinoma.
- •Participants must be eligible for treatment with 6 months of ADT with leuprolide depot or relugolix without additional systemic therapies other than first generation androgen receptor antagonists (eg. bicalutamide, nilutamide, flutamide).
- •Participants cannot have received prior GnRH agonist or antagonist therapy.
- •Patients must have testosterone level \> 200 ng/mL prior to initiation of ADT.
- •Age ≥18 years.
- •ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- •Life expectancy of greater than 12 months
- •Participants must have adequate organ and marrow function as defined below:
- •leukocytes ≥3,000/mcL
- •absolute neutrophil count ≥1,500/mcL
Exclusion Criteria
- •History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
- •Participants who have prior or planned concurrent treatment with second generation AR targeted therapies (such as abiraterone, enzalutamide, darolutamide, apalutamide).
- •Participants who are receiving any other investigational agents.
- •Patients with brain metastases will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide depot or relugolix.
- •Participants with uncontrolled intercurrent illness.
- •Participant is unable to swallow pills.
Arms & Interventions
Arm A: Relugolix
55 participants will be randomized in a 1:1 fashion to Relugolix and stratified by intent to treat with radiation and will complete study procedures as outlined: * Surveys at baseline and at months 3, 6, 9, and 12. * Medication diary entries. * Cycles 1 - 6: --Days 1 - 28 of 28 day cycle: Predetermined dose of Relugolix. Participant will self-administer at home. * Follow up visits every 3 months for 12 months.
Intervention: Relugolix
Arm B: Leuprolide
55 participants will be randomized in a 1:1 fashion to Leuprolide and stratified by intent to treat with radiation and will complete study procedures as outlined: * Surveys at baseline and at months 3, 6, 9, and 12. * Cycle 1 and Cycle 4: --Day 1 of 28 day cycle: Predetermined dose of Leuprolide. Injection will be administered in clinic. * Follow up visits every 3 months for 12 months.
Intervention: Leuprolide
Outcomes
Primary Outcomes
9-month Quality of Life (QOL) Score
Time Frame: At 9 months
The QOL assessed using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire, defined protocol section 11.1.1: The FACT-P (version 4) contains 39 Likert-type items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Secondary Outcomes
- 12-month Quality of Life (QOL) Score(At 12 months)
- 9-month Hot flash related daily interference scale (HFRDIS)(At 9 months)
- 9-month Insomnia Severity Index (ISI) Score(At 9 months)
- 9-month Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score(At 9 months)
- 9-month EPIC-26 Sexual Function Summary Score(At 9 months)
- 12-month Hot flash related daily interference scale (HFRDIS)(At 12 months)