About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Relugolix
Drug
Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
Leuprolide
Drug
Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Arm A: RelugolixExperimental treatment 1 intervention

Group B: Arm B: LeuprolideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

9-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

Secondary outcomes

1

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

2

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

3

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.

Time frame

At 9 months

4

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

RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts