A Phase 3 interventional study of Relugolix and Leuprolide Acetate in Prostate Cancer, sponsored by Myovant Sciences GmbH. Completed at 162 sites in 22 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Myovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 19 studies testing relugolix in Prostatic Neoplasms — 8 open to participants now, 12 under way, 1 of them phase 3. relugolix · Prostatic Neoplasms.
Among the 19 studies testing relugolix in Prostatic Neoplasms, this one has the largest enrollment, is the only one that started in 2017, is one of 3 in phase 3, and was the 5th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
Browse Prostatic Neoplasms studies →8 of the 19 studies testing relugolix in Prostatic Neoplasms are open now, in 1 country. Recruiting first, the newest first:
Baptist Health South Florida · Sites in United States
University of Utah · Sites in United States
Mayo Clinic · Sites in United States
Emory University · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
By country, each count listing its studies:
relugolix: first FDA approval 2020 (ORGOVYX), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2017.
This study's enrollment of 1,134 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 72 across the 19 interventional studies. Of the 7 that completed or were terminated, 6 (86%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 19 have an industry lead sponsor. The 10 most frequent:
Myovant Sciences GmbH is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Myovant Sciences GmbH has 1 study filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies testing relugolix in Prostatic Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05765500Dana-Farber Cancer InstituteRecoverPC: Relugolix vs GnRH Agonist in Quality of Life | 2027-07-01 |
Among the 19 studies testing relugolix in Prostatic Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.
This is a phase 3, multinational, randomized, open-label, parallel group study to evaluate the efficacy and safety of oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous androgen-deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injection will be administered to participants.
There are 2 analyses for this study, a primary analysis and a final analysis.
Primary Analysis:
The primary analysis of efficacy and safety has been completed (N=934). Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up.
Final Analysis:
The final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period. A cohort of participants enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China.
Eligible participants were randomized 2:1 to relugolix or leuprolide arm and will attend visits monthly (every 4 weeks) where serum testosterone and prostate-specific antigen will be assessed. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms.
Castration resistance-free survival will be assessed up to Week 49, Day 1 of the study and reported as part of the final analysis.
The study enrolled 1134 participants, including 139 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of castration resistance-free survival and 93 Chinese participants (enrolled in China and Taiwan) to support registration in China.
Key Inclusion Criteria:
Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relugolix for 48 weeks
Drug: Relugolix
Leuprolide acetate for 48 weeks
Drug: Leuprolide Acetate
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Also known as: TAK-385, MVT-601, RVT-601, T-1331285
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection
Also known as: Leuprolide
Sustained Castration Rate
Sustained castration rate defined as the cumulative probability of testosterone suppression to \< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.
Time frame: From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
Castration Rate At Week 1 Day 4
Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 1 Day 4 (Day 4)
Castration Rate At Week 3 Day 1
Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 3 Day 1 (Day 15)
Confirmed Prostate-specific Antigen (PSA) Response Rate
Confirmed PSA response defined as \> 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1.
Time frame: Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)
Profound Castration Rate At Week 3 Day 1 (Day 15)
Castration rate defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 3 Day 1 (Day 15)
Follicle-stimulating Hormone (FSH) Level
To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.
Time frame: Week 25 Day 1 (Day 169)
PSA Response Rate At Week 3 Day 1
PSA response defined as \> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 3 Day 1 (Day 15)
PSA Response Rate At Week 5 Day 1
PSA response defined as \> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 5 Day 1 (Day 29)
Testosterone Recovery Rate
The cumulative probability of testosterone recovery back to \> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Day 90 follow-up
Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1
Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)
Profound Castration Rate At Week 1 Day 4 (Day 4)
Castration rate defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Time frame: At Week 1 Day 4 (Day 4)
Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1
Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)
Undetectable PSA Rate
Defined as the proportion of participants with PSA concentration \< 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 25 Day 1 (Day 169)
Rate Of PSA Progression-free Survival
PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants.
Time frame: Week 49 Day 1 (Day 337)
Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30
The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time frame: Baseline, Week 49 Day 1 (Day 337)
Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30
The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time frame: Baseline, Week 49 Day 1 (Day 337)
Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains
Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time frame: Baseline, Week 49 Day 1 (Day 337)
Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25
Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Time frame: Baseline, Week 49 Day 1 (Day 337)
Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L)
The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement.
Time frame: Baseline, Week 49 Day 1 (Day 337)
Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone
Blood samples were collected from participants for hormonal measurements.
Time frame: Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Percent Change From Baseline In Serum Concentrations Of FSH
Blood samples were collected from participants for hormonal measurements.
Time frame: Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone
Blood samples were collected from participants for hormonal measurements.
Time frame: Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin
Blood samples were collected from participants for hormonal measurements.
Time frame: Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)
Maximum Observed Plasma Concentration (Cmax) Of Relugolix
The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix
The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix
The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2
Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)
MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.
Time frame: From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
To support registration in China, the study continued to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 90 participants.
| Milestone | Relugolix | Leuprolide Acetate |
|---|---|---|
| Started | 624 | 310 |
| Received at least 1 dose of study drug | 622 | 308 |
| Completed | 563 | 276 |
| Not completed | 61 | 34 |
| Withdrew: Adverse event | 23 | 8 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 17 | 6 |
| Withdrew: Physician decision | 9 | 3 |
| Withdrew: Testosterone suppression level not met | 7 | 13 |
| Withdrew: Did not receive study drug | 2 | 2 |
| Withdrew: Dosing interruption (logistical reason) | 1 | 0 |
Sustained castration rate defined as the cumulative probability of testosterone suppression to \< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Sustained Castration Rate | 96.7 (94.9 to 97.9) | 88.8 (84.6 to 91.8) |
Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Castration Rate At Week 1 Day 4 | 56.04 (52.18 to 59.97) | 0.00 (NA to NA) |
Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Castration Rate At Week 3 Day 1 | 98.71 (97.56 to 99.39) | 12.05 (8.88 to 16.25) |
Confirmed PSA response defined as \> 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Confirmed Prostate-specific Antigen (PSA) Response Rate | 79.4 (76.03 to 82.53) | 19.8 (15.50 to 24.70) |
Castration rate defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Profound Castration Rate At Week 3 Day 1 (Day 15) | 78.38 (75.06 to 81.53) | 0.98 (0.32 to 3.00) |
To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.
| IU/L | Relugolix | Leuprolide Acetate |
|---|---|---|
| Follicle-stimulating Hormone (FSH) Level | 1.72 ± 1.376 | 5.95 ± 3.071 |
PSA response defined as \> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| PSA Response Rate At Week 3 Day 1 | 80.1 (76.70 to 83.14) | 20.1 (15.80 to 25.05) |
PSA response defined as \> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| PSA Response Rate At Week 5 Day 1 | 94.5 (92.44 to 96.19) | 79.2 (74.26 to 83.61) |
The cumulative probability of testosterone recovery back to \> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| ≥ 50 ng/dL | 93.01 (87.82 to 96.54) | 10.12 (3.84 to 25.24) |
| > 280 ng/dL | 53.93 (45.20 to 63.16) | 3.23 (0.46 to 20.77) |
| > Baseline level or 280 ng/dL | 54.73 (45.97 to 63.94) | 3.23 (0.46 to 20.77) |
Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1 | 81.6 (78.1 to 84.5) | 68.6 (63.0 to 73.5) |
Castration rate defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Profound Castration Rate At Week 1 Day 4 (Day 4) | 6.92 (5.18 to 9.22) | 0.0 (NA to NA) |
Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1 | 84.6 (81.3 to 87.3) | 87.5 (83.0 to 90.8) |
Defined as the proportion of participants with PSA concentration \< 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Undetectable PSA Rate | 20.7 (17.62 to 24.14) | 20.8 (16.39 to 25.74) |
PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Rate Of PSA Progression-free Survival | 89.31 (86.52 to 91.55) | 89.50 (85.39 to 92.50) |
The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
| score on a scale | Relugolix | Leuprolide Acetate |
|---|---|---|
| Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30 | -3.8 ± 18.13 | -3.6 ± 15.70 |
The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
| score on a scale | Relugolix | Leuprolide Acetate |
|---|---|---|
| Physical functioning | -4.6 ± 13.09 | -4.4 ± 12.29 |
| Role functioning | -6.2 ± 19.92 | -5.6 ± 17.84 |
| Emotional functioning | 0.5 ± 16.12 | -0.5 ± 13.23 |
| Cognitive functioning | -3.7 ± 16.77 | -3.8 ± 16.37 |
| Social functioning | -2.7 ± 18.31 | -4.0 ± 18.18 |
| Fatigue | 6.1 ± 19.46 | 7.0 ± 18.40 |
| Nausea and vomiting | 0.2 ± 7.12 | 0.8 ± 6.02 |
| Pain | 1.7 ± 20.19 | 4.0 ± 21.96 |
| Dyspnoea | 5.3 ± 19.16 | 7.9 ± 20.25 |
| Insomnia | 4.8 ± 25.88 | 4.8 ± 21.82 |
| Appetite loss | -0.6 ± 17.82 | -0.6 ± 14.86 |
| Constipation | 1.4 ± 23.26 | 3.5 ± 18.88 |
| Diarrhoea | 2.0 ± 16.70 | 1.4 ± 19.60 |
| Financial difficulties | 0.2 ± 18.28 | 0.1 ± 19.21 |
Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
| score on a scale | Relugolix | Leuprolide Acetate |
|---|---|---|
| Sexual activity | 13.9 ± 26.51 | 10.8 ± 27.90 |
| Sexual functioning | -9.0 ± 23.37 | -10.4 ± 21.10 |
| Hormonal treatment-related symptoms | 10.6 ± 12.25 | 11.4 ± 13.30 |
Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).
| score on a scale | Relugolix | Leuprolide Acetate |
|---|---|---|
| Urinary symptoms | 1.1 ± 15.29 | -0.4 ± 13.78 |
| Incontinence aid use | 1.0 ± 15.41 | 0.0 ± 19.80 |
| Bowel symptoms | 1.2 ± 8.92 | 2.0 ± 9.51 |
The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement.
| score on a scale | Relugolix | Leuprolide Acetate |
|---|---|---|
| Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L) | -1.5 ± 14.36 | -2.7 ± 14.57 |
Blood samples were collected from participants for hormonal measurements.
| Percent change | Relugolix | Leuprolide Acetate |
|---|---|---|
| Week 1 Day 4 (Day 4) | -88.25 ± 20.696 | 147.71 ± 122.735 |
| Week 5 Day 1 (Day 29) | -94.54 ± 8.500 | -82.67 ± 27.146 |
| Week 25 Day 1 (Day 169) | -93.93 ± 7.242 | -93.45 ± 13.202 |
| Week 49 Day 1 (Day 337) | -91.54 ± 16.779 | -95.14 ± 4.507 |
Blood samples were collected from participants for hormonal measurements.
| percent change | Relugolix | Leuprolide Acetate |
|---|---|---|
| Week 1 Day 4 (Day 4) | -62.59 ± 9.051 | -4.74 ± 36.121 |
| Week 5 Day 1 (Day 29) | -90.80 ± 8.151 | -67.73 ± 27.311 |
| Week 25 Day 1 (Day 169) | -86.32 ± 10.699 | -47.53 ± 32.560 |
| Week 49 Day 1 (Day 337) | -79.39 ± 21.987 | -47.23 ± 30.112 |
Blood samples were collected from participants for hormonal measurements.
| percent change | Relugolix | Leuprolide Acetate |
|---|---|---|
| Week 5 Day 1 (Day 29) | -87.61 ± 12.225 | -81.95 ± 23.733 |
| Week 25 Day 1 (Day 169) | -88.06 ± 11.810 | -85.45 ± 32.261 |
| Week 49 Day 1 (Day 337) | -88.23 ± 11.235 | -87.56 ± 12.088 |
Blood samples were collected from participants for hormonal measurements.
| percent change | Relugolix | Leuprolide Acetate |
|---|---|---|
| Week 5 Day 1 (Day 29) | 1.08 ± 22.068 | -1.21 ± 20.430 |
| Week 25 Day 1 (Day 169) | 7.24 ± 28.265 | 3.59 ± 24.947 |
| Week 49 Day 1 (Day 337) | 6.54 ± 28.787 | 2.59 ± 27.051 |
The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
| ng/mL | Relugolix Single-Dose | Relugolix Repeat-Dose |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Of Relugolix | 125 ± 220 | 46.4 ± 141 |
The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
| ng⸳hr/mL | Relugolix Single-Dose | Relugolix Repeat-Dose |
|---|---|---|
| Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix | 663 ± 151 | 373 ± 51 |
The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.
| hours | Relugolix Single-Dose | Relugolix Repeat-Dose |
|---|---|---|
| Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix | 1.03 (0.400 to 4.05) | 0.983 (0.433 to 4.08) |
MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.
| percentage of participants | Relugolix | Leuprolide Acetate |
|---|---|---|
| Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE) | 2.9 | 6.2 |
Collected over Day 1 (after dosing) through up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relugolix | 7/622 (1.1%) | 76/622 (12.2%) | 493/622 (79.3%) |
| Leuprolide Acetate | 9/308 (2.9%) | 47/308 (15.3%) | 239/308 (77.6%) |
| Event | Relugolix | Leuprolide Acetate |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/622 | 3/308 |
| Cardio-respiratory arrestCardiac disorders | 0/622 | 3/308 |
| Transient ischaemic attackNervous system disorders | 0/622 | 3/308 |
| Acute myocardial infarctionCardiac disorders | 5/622 | 1/308 |
| Inguinal herniaGastrointestinal disorders | 0/622 | 2/308 |
| Urinary tract infectionInfections and infestations | 3/622 | 2/308 |
| Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/622 | 2/308 |
| Cerebral haemorrhageNervous system disorders | 0/622 | 2/308 |
| PresyncopeNervous system disorders | 0/622 | 2/308 |
| SyncopeNervous system disorders | 0/622 | 2/308 |
| Event | Relugolix | Leuprolide Acetate |
|---|---|---|
| Hot flushVascular disorders | 338/622 | 159/308 |
| FatigueGeneral disorders | 134/622 | 57/308 |
| ConstipationGastrointestinal disorders | 76/622 | 30/308 |
| DiarrhoeaGastrointestinal disorders | 76/622 | 21/308 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 75/622 | 28/308 |
| HypertensionVascular disorders | 49/622 | 36/308 |
| NasopharyngitisInfections and infestations | 59/622 | 29/308 |
| Back painMusculoskeletal and connective tissue disorders | 50/622 | 28/308 |
| Weight increasedInvestigations | 49/622 | 20/308 |
| InsomniaPsychiatric disorders | 43/622 | 14/308 |
All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.
| Age, Continuous(years) | Relugolix | Leuprolide Acetate | Total |
|---|---|---|---|
| Mean | 71.2 ± 7.75 | 71.0 ± 8.03 | 71.1 ± 7.84 |
| Sex: Female, Male(Participants) | Relugolix | Leuprolide Acetate | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 622 | 308 | 930 |
| Ethnicity (NIH/OMB)(Participants) | Relugolix | Leuprolide Acetate | Total |
|---|---|---|---|
| Hispanic or Latino | 52 | 31 | 83 |
| Not Hispanic or Latino | 558 | 269 | 827 |
| Unknown or Not Reported | 12 | 8 | 20 |
| Race (NIH/OMB)(Participants) | Relugolix | Leuprolide Acetate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 127 | 71 | 198 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 30 | 16 | 46 |
| White | 434 | 202 | 636 |
| More than one race | 11 | 4 | 15 |
| Unknown or Not Reported | 20 | 15 | 35 |
Showing the first 100 of 162 sites across 22 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2017 to primary completion in Oct 2019, 30 months.
Results were first posted in Mar 2021, 1 year 5 months after primary completion. A results delay was requested in Oct 2020.
Of 126 industry-sponsored phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 53. This study's 30 months is below that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Relugolix