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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States
RECRUITING9-month Quality of Life (QOL) Score
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.
Time frame: At 9 months
12-month Quality of Life (QOL) Score
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.
Time frame: At 12 months
9-month Hot flash related daily interference scale (HFRDIS)
HFRDIS was Self-reported daily hot flash interference will be assessed with the Hot Flash-Related Daily Interference Scale, a valid and reliable measure used in prior prostate cancer studies. This scale assesses the impact of hot flashes on daily activities as well as overall quality of life. Total scores range from 0 - 100; higher scores indicate greater interference.
Time frame: At 9 months
9-month Insomnia Severity Index (ISI) Score
ISI Insomnia symptoms will be assessed using the ISI, which has been used in previous assessments of cancer patients, including men with prostate cancer. This questionnaire has 7 items asking about difficulties falling asleep, staying asleep, problems with waking too early and the satisfaction level with their current sleep pattern. Each item was rated on a scale from 0 to 4, where a higher score indicates a more severe insomnia.
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Time frame: At 9 months
9-month Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Fatigue symptoms will be assessed with the FACIT-Fatigue survey, a valid and reliable instrument used in prostate cancer and other cancer studies, comprised of 13 items and rated on a 5 point Likert-type scale.
Time frame: At 9 months
9-month EPIC-26 Sexual Function Summary Score
Self-reported sexual function will be assessed using the sexual health section of the EPIC-26.
Time frame: At 9 months
12-month Hot flash related daily interference scale (HFRDIS)
HFRDIS was Self-reported daily hot flash interference will be assessed with the Hot Flash-Related Daily Interference Scale. This scale assesses the impact of hot flashes on daily activities as well as overall quality of life. Total scores range from 0 - 100; higher scores indicate greater interference.
Time frame: At 12 months