Prostate CancerPhase 2NCT05765500
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
A Phase 2 study testing Relugolix and Leuprolide in people with Prostate Cancer and Prostatic Neoplasms, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- Relugolix and Leuprolide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Feb 2024to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 22Show fewer
- 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
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN) unless known or suspected Gilbert syndrome
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- creatinine ≤ institutional ULN OR
- glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B).
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
- The effects of relugolix and leuprolide on the developing human fetus are unknown. For this reason and because GnRH agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of relugolix or leuprolide depot administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Alicia Morgans, MD, 857-215-1605, aliciak_morgans@dfci.harvard.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Alicia Morgans, MD, 857-215-1605, aliciak_morgans@dfci.harvard.edu
- Recruiting
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Daniel Roberts, MD, 508-543-1700, Daniel_Roberts@DFCI.HARVARD.EDU
About this study
Official title: RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer
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)
Read the 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.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- Relugolix, Leuprolide
- Keywords
- Prostate Cancer, Prostate Neoplasms
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelugolixDrug
Also called Orgovyx
Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
LeuprolideDrug
Also called Leuprolide Depot
Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Relugolix | Experimental | 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. Receives: Drug: Relugolix |
| Arm B: Leuprolide | Active comparator | 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. Receives: Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 9 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start12 Feb 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation, Pfizer, Sumitomo Pharma America, Inc.
- Responsible party
- Principal investigator, Alicia Morgans, Dana-Farber Cancer Institute
- Investigators
- Alicia Morgans, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765500
- Sponsor's protocol ID
- 22-599
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05765500
- Acronym / sponsor ID
- 22-599
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- Prostate Cancer, Prostate Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation, Pfizer, Sumitomo Pharma America, Inc.
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Relugolix | Experimental | Drug: Relugolix55 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. |
| Arm B: Leuprolide | Active comparator | Drug: Leuprolide55 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelugolixAlso: OrgovyxGonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily. | Drug | Arm A: Relugolix |
| LeuprolideAlso: Leuprolide DepotGonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months. | Drug | Arm B: Leuprolide |
Primary outcome
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.
6 secondary outcomes
12-month Quality of Life (QOL) Score
Time frame: At 12 months
9-month Hot flash related daily interference scale (HFRDIS)
Time frame: At 9 months
9-month Insomnia Severity Index (ISI) Score
Time frame: At 9 months
9-month Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Time frame: At 9 months
9-month EPIC-26 Sexual Function Summary Score
Time frame: At 9 months
12-month Hot flash related daily interference scale (HFRDIS)
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia Morgans, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relugolix and Leuprolide in people with Prostate Cancer and Prostatic Neoplasms, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia Morgans, MD (857-215-1605, aliciak_morgans@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-month Quality of Life (QOL) Score (time frame: At 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.