Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT05765500
Brief 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. 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:
NCT05765500
Study Brief:
Protocol Section:
NCT05765500