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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06129851
Other study ID # STUDY00150674
Secondary ID NCI-2023-09079ST
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 20, 2023
Est. completion date October 23, 2026

Study information

Verified date November 2023
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
United States University of Kansas Cancer Center Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemical recurrence Will be defined as serum prostate-specific antigen (PSA) level of nadir + 2 ng/mL by blood test. Up to 3 years
Secondary Composite quality of Life Will be assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) and will be compared between the 2 arms in terms of hormonal domain and sexual domain of EPIC-26. An area under the curve (AUC) metric will be utilized to account for the overall quality of life from baseline through 36 months for each patient. A mixed effect model will be employed to construct an estimate of the difference in AUC between Arms A and B, including fixed effects of time, arm, and baseline characteristics (two or three covariates depending on the available sample size). A two-sample t-test with a significance level of 0.05 will be performed. Up to 5 years
Secondary Incidence of adverse events Will be assessed by Common Terminology Criteria for Adverse Events version 5.0 and will be reported descriptively. Up to 5 years
Secondary Incidence of major adverse cardiovascular events Will be assessed by medical record review and will be reported descriptively. Up to 5 years
Secondary Participant compliance Will be assessed by patient study diary. Up to 2 years
Secondary Time to testosterone recovery Will be assessed by blood tests and the percentage of patients in each arm who achieved baseline level or minimum 280 ng/dL will be reported at 3-month intervals up through 36 months after treatment completion. Up to 5 years
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