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:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT07142551
Brief Summary:
The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Detailed Description:
This research is being done to determine if alternating high dose testosterone and prevent the development of resistance to hormone therapy. It is also being done to determine if this alternating therapy can decease the side effects of hormone therapy and improve the participant's quality of life.
Right now, patients who develop metastatic prostate cancer are treated with medications that block testosterone effects as first-line therapy. Eventually, the testosterone blocking therapies become ineffective and the tumor begins to grow. The investigaors call this phase of the disease castrater-resistant prostate cancer (CRPC). Previous research has shown that prostate cancer cells can eventually adapt to low testosterone conditions produced by hormone therapy and begin to grow again. The investigators have learned that these resistant prostate cancer cells can killed by high levels of testosterone followed by a rapid drop to low testosterone levels. The investigators call this treatment bipolar androgen therapy (BAT) because the investigators are going from the polar extremes of high and low testosterone in the blood every 28 days. The investigators have tested this idea in previous studies by giving injections of high doses of testosterone to patients with CRPC. In these trials, the investigators saw that BAT was safe. BAT produced decreases in PSA levels and decreases in tumor size in some patients. After treatment with BAT, many patients had an improved response to the testosterone-blocking drug enzalutamide. The drug used in this study, darolutamide, is similar to enzalutamide. Both drugs are considered to be antiandrogens that block effects of testosterone within the prostate cancer cells.
The investigators also did a study called the BATMAN study in patients with mHSPC. These patients received alternating therapy with high dose testosterone and ADT as first line therapy. In this study, alternating testosterone and ADT was found to be safe. In this study, more patients remained sensitive to hormone therapy after 18 months than the investigators would have expected with ADT alone.
In this study, the investigators would like to see if improvement on these results and decrease hormonal side effects when the investigators give testosterone in sequence with darolutamide.
Study:
NCT07142551
Study Brief:
Protocol Section:
NCT07142551