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GnRH Antagonist

SBRT + Relugolix for Prostate Cancer

Q: Does this trial still have space for new participants?

<p>According to the information provided on clinicaltrials.gov, this research is not currently recruiting volunteers. The study was first posted on January 15th 2024 and last updated October 26th 2023; however, 1352 other medical trials are actively enrolling patients at present.</p>

Q: Has the FDA given its stamp of approval to Stereotactic body radiotherapy?

<p>There is existing evidence that suggests Stereotactic body radiotherapy has a high level of safety, thus it was assigned an overall rating of 3.</p>

Phase 2

Recruiting

Led By James Yu

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post treatment

Awards & highlights

Study Summary

This trial tests if a new drug combined with radiation therapy is more effective than radiation therapy alone for treating prostate cancer. #prostatecancer #radiationtherapy #drugs

Who is the study for?

Men aged 18+ with specific types of prostate cancer (cFIR/cgUIR) can join. They must have a Gleason score of 3+4 with PSA <20 ng/mL or Gleason 6 and PSA between >10 and <20 ng/mL. Excluded are those on recent investigational drugs, with heart issues like long QT syndrome, history of surgical castration, prior prostate cancer treatments, certain medication use, allergies to relugolix, inflammatory bowel diseases, connective tissue diseases or if GNRH/SBRT therapy is not suitable.Check my eligibility

What is being tested?

This trial tests the effectiveness and safety of SBRT alone versus SBRT combined with an oral drug called Relugolix in treating cFIR/cgUIR prostate cancer. It aims to see if combining these treatments improves PSA levels better than SBRT alone and assesses their impact on sexual and hormonal function at six months.See study design

What are the potential side effects?

Possible side effects include allergic reactions to Relugolix; heart issues such as prolonged QT interval which could lead to arrhythmias; potential aggravation of ulcerative colitis or other inflammatory bowel diseases; exacerbation of connective tissue disorders like lupus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants that attain PSA nadir

Secondary outcome measures

Change in Quality of life assessment using the EPIC-26 survey

Trial Design

2Treatment groups

Active Control

Group I: Stereotactic body radiotherapyActive Control1 Intervention

SBRT Though a range of doses are delivered nationally for IR prostate cancer, the most common regimen is 7.25 Gy- 8.00 Gy x 5 fractions, given over 2 weeks.

Group II: Relugolix and SBRTActive Control2 Interventions

SBRT and Relugolix SBRT along with 30 days of total relugolix (study drug) will be used. Relugolix starting 14 days to 17 days prior to the first treatment.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,966 Total Patients Enrolled

41 Trials studying Prostate Cancer

12,310 Patients Enrolled for Prostate Cancer

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,381 Total Patients Enrolled

5 Trials studying Prostate Cancer

832 Patients Enrolled for Prostate Cancer

James YuPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial still have space for new participants?

"According to the information provided on clinicaltrials.gov, this research is not currently recruiting volunteers. The study was first posted on January 15th 2024 and last updated October 26th 2023; however, 1352 other medical trials are actively enrolling patients at present."

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