All > Prostate Cancer

Arm A: Relugolix for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dana-Farber Cancer Institute, Boston, MAProstate Cancer+1 MoreRelugolix - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial tests how the standard prostate cancer treatments, Leuprolide & Relugolix, affect quality of life, blood levels, cholesterol, & blood sugar.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: At 9 months

At 12 months
12-month Hot flash related daily interference scale (HFRDIS)
12-month Quality of Life (QOL) Score
At 9 months
9-month EPIC-26 Sexual Function Summary Score
9-month Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
9-month Hot flash related daily interference scale (HFRDIS)
9-month Insomnia Severity Index (ISI) Score
9-month Quality of Life (QOL) Score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

Relugolix Plus E2/NETA (Group A)
11%Hot flush
11%Headache
5%Hypertension
3%Arthralgia
1%Hypothyroidism
1%uterine leiomyoma
1%Menorrhagia
1%Haematemesis
1%Cough
1%Avulsion fracture
1%Vitreous detachment
1%Uterine myoma expulsion
1%Pelvic pain
1%Upper respiratory tract infection
1%Ankle fracture
1%Rhabdomyolysis
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03049735) in the Relugolix Plus E2/NETA (Group A) ARM group. Side effects include: Hot flush with 11%, Headache with 11%, Hypertension with 5%, Arthralgia with 3%, Hypothyroidism with 1%.

Trial Design

2 Treatment Groups

Arm B: Leuprolide
1 of 2
Arm A: Relugolix
1 of 2

Active Control

Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A: Relugolix · No Placebo Group · Phase 2

Arm A: Relugolix
Drug
Experimental Group · 1 Intervention: Relugolix · Intervention Types: Drug
Arm B: Leuprolide
Drug
ActiveComparator Group · 1 Intervention: Leuprolide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relugolix
2016
Completed Phase 3
~4450

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 9 months

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,026 Previous Clinical Trials
753,849 Total Patients Enrolled
68 Trials studying Prostate Cancer
16,111 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
40 Previous Clinical Trials
2,142 Total Patients Enrolled
24 Trials studying Prostate Cancer
1,653 Patients Enrolled for Prostate Cancer
PfizerIndustry Sponsor
4,356 Previous Clinical Trials
7,174,000 Total Patients Enrolled
39 Trials studying Prostate Cancer
11,748 Patients Enrolled for Prostate Cancer
Myovant Sciences GmbHIndustry Sponsor
19 Previous Clinical Trials
11,211 Total Patients Enrolled
4 Trials studying Prostate Cancer
4,434 Patients Enrolled for Prostate Cancer
Alicia Morgans, MDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · Male Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Has the FDA sanctioned Relugolix for pharmaceutical use?

"With clinical data confirming a certain level of safety and the lack of evidence suggesting efficacy, Arm A: Relugolix received a score of 2." - Anonymous Online Contributor

Unverified Answer

Is there still availability for participation in this research endeavor?

"The information displayed on clinicaltrials.gov reveals that this medical study is not presently seeking applicants, however it was initially published on August 1st 2023 and last updated March 1st of the same year. Although no longer recruiting patients, there are 1318 other trials currently enrolling participants." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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