Testosterone Replacement Therapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer who are monitored rather than treated aggressively (known as active surveillance) and have low testosterone levels. Participants will self-inject testosterone cypionate, a form of testosterone replacement therapy, weekly for a year. This trial suits men diagnosed with low-risk prostate cancer within the last year, who experience symptoms of low testosterone, and can access testosterone medication through insurance or out-of-pocket. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.
Do I need to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude those currently using testosterone replacement therapy.
What is the safety track record for testosterone cypionate?
Research shows that testosterone replacement therapy (TRT) is generally safe for men. Studies have found that TRT does not significantly increase the risk of prostate cancer recurrence or progression after initial treatment. One study found prostate cancer in 0.5% of men using testosterone, compared to 0.4% of those not using it, indicating a very small difference.
Testosterone therapy has been linked to a slightly higher risk of benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate. However, evidence suggests that TRT does not significantly increase the risk of developing new prostate cancer.
Overall, TRT has been used safely in men, even those with a history of prostate cancer, without major concerns. This study aims to further explore its safety in men with low-risk prostate cancer and low testosterone levels (hypogonadism).12345Why are researchers enthusiastic about this study treatment?
Testosterone cypionate is unique because it challenges the traditional approach to prostate cancer treatment. Most treatments for prostate cancer focus on reducing testosterone levels, as the hormone can fuel cancer growth. However, testosterone cypionate takes a different route by actually adding testosterone, aiming to disrupt cancer cells' ability to adapt and survive without the hormone. Researchers are excited about this treatment because it could potentially reverse the cancer's growth or make it more susceptible to other therapies, offering a new hope for patients who have limited options.
What evidence suggests that testosterone replacement therapy might be an effective treatment for low-risk prostate cancer?
Research has shown that testosterone replacement therapy (TRT) can be safe for men with prostate cancer. In this trial, participants will receive testosterone cypionate, a form of TRT. Studies have found that men using TRT are 54% less likely to experience a recurrence of prostate cancer. Another study discovered that TRT does not significantly raise prostate-specific antigen (PSA) levels, which doctors often monitor in prostate cancer patients. Additionally, TRT has been linked to a 15% lower long-term risk of developing prostate cancer. Overall, testosterone cypionate appears to improve quality of life without increasing the risk of prostate cancer progression.23678
Who Is on the Research Team?
Thomas Masterson, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for men with low-risk prostate cancer who are being closely monitored (active surveillance) and also have hypogonadism, a condition where the body doesn't produce enough testosterone. Specific eligibility details aren't provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-inject 100mg of testosterone cypionate once per week
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Testosterone cypionate
Trial Overview
The study is testing the safety of giving testosterone cypionate, a hormone replacement therapy, to men with low-risk prostate cancer and hypogonadism to see if it's safe and doesn't worsen their cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will self-inject 100mg of testosterone cypionate once per week for 12 months
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
The Effect of Testosterone Replacement Therapy on ...
The results of this study indicate that testosterone replacement therapy does not increase PSA levels in men being treated for hypogonadism, except when it is ...
Association Between Testosterone Replacement Therapy and ...
Similarly, long-term TRT use demonstrated a similar 15% reduced hazard of PCa and a 13% increased hazard of BPH. These results align with previous study ...
3.
auanews.net
auanews.net/issues/articles/2022/april-2022/testosterone-therapy-for-patients-with-a-history-of-prostate-cancerTestosterone Therapy for Patients with a History of Prostate ...
Patients on TTh were almost 54% less likely to have a prostate cancer recurrence. In men expected to have a prostate specific antigen (PSA) ...
Testosterone therapy and prostate cancer - Pastuszak
TTh results in improvements in quality of life with little evidence of biochemical recurrence or progression in men with a history of CaP, or de novo cancer in ...
Cardiovascular Safety of Testosterone-Replacement Therapy
Prostate cancer occurred in 12 patients (0.5%) in the testosterone group and in 11 patients (0.4%) in the placebo group (P=0.87); these cases were adjudicated ...
Testosterone Replacement Therapy and Prostate Cancer ...
Investigators have reported favorable outcomes with testosterone supplementation after radical prostatectomy.
SUO 2024: Testosterone Supplementation After Treatment ...
Early data has not demonstrated any increased risk of prostate cancer recurrence or progression in men using TRT after prostate cancer ...
Testosterone Replacement Therapy in Hypogonadal ...
The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and ...
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