Testosterone Replacement Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Roswell Park Cancer Institute

Must be taking: Testosterone replacement

Disqualifiers: Advanced cancer, Breast cancer, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether testosterone replacement therapy (TRT) can improve quality of life and treatment outcomes for men with low testosterone who have localized prostate cancer and are under active surveillance. Active surveillance involves closely monitoring the cancer without immediate treatment unless changes occur. Typically, TRT is avoided in prostate cancer patients due to concerns about encouraging cancer growth. However, the study aims to determine if TRT can help without causing harm. Men with non-spreading prostate cancer and low testosterone symptoms, such as low libido or erectile issues, might be suitable for this trial. Participants will either receive TRT or continue standard surveillance to compare outcomes. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for therapeutic testosterone?

Research has shown that testosterone replacement therapy (TRT) might be safe for men with prostate issues. Some studies have found no connection between TRT and the growth or return of prostate cancer. For example, after one year of TRT, researchers observed no change in PSA levels—a protein that can signal prostate cancer—in men with certain prostate conditions. Another study suggested that TRT might even reduce the risk of aggressive prostate cancer. Overall, while some concerns remain, TRT has not been shown to increase the risk of prostate cancer in men undergoing the therapy. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about testosterone replacement therapy (TRT) for prostate cancer because it offers a novel approach by addressing low testosterone levels in patients experiencing hypogonadal symptoms. Unlike traditional treatments such as surgery, radiation, or hormone therapy that typically aim to lower testosterone to combat cancer, TRT introduces therapeutic testosterone to potentially improve quality of life and manage symptoms. This treatment is particularly intriguing as it challenges the conventional belief that higher testosterone levels always exacerbate prostate cancer, opening up new possibilities for managing the disease while maintaining patient well-being.

What evidence suggests that testosterone replacement therapy might be an effective treatment for hypogonadal men with localized prostate cancer?

This trial will compare different approaches for managing testosterone levels in men with localized prostate cancer. Research has shown that testosterone replacement therapy (TRT), which participants in Group 2 may receive, does not increase the risk of prostate cancer growing or spreading. Studies have found that TRT can improve symptoms like low sex drive and energy levels in men with low testosterone, without increasing the need for more serious cancer treatments or raising death rates. One study found no significant changes in prostate-specific antigen (PSA) levels, often used to monitor prostate cancer, in men on TRT. Overall, TRT appears to be a safe option for managing low testosterone in men with localized prostate cancer and may help improve their quality of life. ^{2 4 6 7 8}

Who Is on the Research Team?

Ahmed Aly

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for men with low testosterone (hypogonadism) who also have localized prostate cancer and are being monitored without active treatment (active surveillance). It's not specified here, but typically participants would need to meet certain health criteria and agree to the study procedures.

Inclusion Criteria

I am a man aged 18 or older.

Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

I am a man with early-stage prostate cancer considered low-risk and eligible for monitoring.

Exclusion Criteria

Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study

Unwilling or unable to follow protocol requirements

My prostate cancer is at an intermediate unfavorable, high, or very high risk but has not spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Surveillance

Participants undergo active surveillance with regular monitoring through blood tests, MRI, and potential prostate biopsy

Up to 5 years

Regular visits for blood tests and MRI

Testosterone Replacement Therapy (TRT)

Participants with low testosterone levels receive TRT via injection, gel, lotion, or transdermal patch

Up to 5 years

Regular visits for TRT administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Therapeutic Testosterone

Trial Overview The trial is studying the effects of testosterone replacement therapy on men with low testosterone levels and localized prostate cancer under observation. The study includes regular exams, blood tests, biopsies, MRI scans, and questionnaires to monitor outcomes.

How Is the Trial Designed?

Group I: Group 2 (TRT, AS) Experimental Treatment 6 Interventions

Patients with low testosterone level associated with hypogonadal symptoms and willing to receive TRT receive testosterone per treating physician discretion via injection, gel, lotion, or transdermal patch and undergo standard AS for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.

Group II: Group 1 (AS) Active Control 5 Interventions

Patients with normal testosterone level undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.

Group III: Group 3 (AS) Active Control 5 Interventions

Patients with low testosterone level with no symptoms, or low testosterone level associated with hypogonadal symptoms but declined TRT undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

Testosterone replacement therapy (TRT) is the primary treatment for male hypogonadism, which is often linked to age, obesity, and diabetes, and may be safe for certain patients with prostate cancer.

Recent evidence indicates that TRT may not necessarily lead to the progression of prostate cancer, suggesting a need for further research to clarify its safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of androgen therapy in men with prostate cancer. Rajan, P., Tharakan, T., Chen, R.[2022]

Testosterone replacement therapy (TRT) does not appear to significantly increase the risk of disease progression in men with prostate cancer compared to those not receiving TRT, based on a systematic review of 36 studies involving 2,459 patients.

However, TRT may be harmful for men with advanced prostate cancer, those undergoing active surveillance, and those with high-risk disease after treatment, indicating that caution is needed in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy in Men with Untreated or Treated Prostate Cancer: Do We Have Enough Evidences? Kim, M., Byun, SS., Hong, SK.[2021]

Testosterone replacement therapy in hypogonadal men with prostate cancer after radical prostatectomy was found to be effective, leading to significant increases in testosterone levels without increasing cancer recurrence rates, even in high-risk patients.

While there was an increase in prostate-specific antigen (PSA) levels following testosterone therapy, this did not correlate with higher rates of cancer recurrence compared to a reference group, suggesting that testosterone therapy can be safely monitored in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone replacement therapy in patients with prostate cancer after radical prostatectomy. Pastuszak, AW., Pearlman, AM., Lai, WS., et al.[2021]

Recent evidence suggests that testosterone therapy can be safely offered to many men with prostate cancer, challenging the outdated prohibition based on concepts from over 70 years ago.

Men with prostate cancer who have symptoms of testosterone deficiency may experience significant improvements in their quality of life with testosterone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone Therapy in a Man with Intermediate-risk Prostate Cancer: Pro. Morgentaler, A.[2021]

In a study of 1303 men who underwent robotic-assisted radical prostatectomy (RARP), testosterone replacement therapy (TRT) was found to be oncologically safe, with only 6.4% of TRT patients experiencing biochemical recurrence (BCR) compared to 12.56% in non-TRT patients.

TRT significantly improved sexual health and serum testosterone levels in patients, indicating that it can be a functionally effective treatment for men experiencing symptoms of andropause after prostate cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological safety and functional outcomes of testosterone replacement therapy in symptomatic adult-onset hypogonadal prostate cancer patients following robot-assisted radical prostatectomy. Shahine, H., Zanaty, M., Zakaria, AS., et al.[2022]

Testosterone replacement therapy may be a safe option for certain hypogonadal men with low-risk prostate cancer who are undergoing treatment with curative intent, as long as there is no active disease present.

Current evidence supporting this approach is limited, indicating that careful selection of patients is crucial before considering testosterone therapy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Hypogonadism in Low-Risk Prostate Cancer Survivors. Agrawal, L., Arceo-Mendoza, RM., Barnosky, A., et al.[2020]

Exogenous testosterone therapy in hypogonadal men can lead to prostate volumes similar to those of men with normal testosterone levels, with only modest increases in PSA levels and minor changes in urinary flow, suggesting a relatively safe profile for prostate health.

Current evidence indicates that while testosterone does not cause prostate cancer, it can exacerbate existing prostate malignancies; however, there is no causal link between testosterone treatment and the development of prostate cancer in hypogonadal elderly men, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen replacement therapy and prostate safety. Morales, A.[2019]

In a study of 69,984 men with localized prostate cancer, testosterone therapy (TT) after treatment did not increase the risk of biochemical recurrence or mortality, indicating its safety for patients post-treatment.

Among the 469 men who received TT after surgery and 543 after radiation, there were no significant differences in cancer-specific or overall mortality compared to those who did not receive TT, suggesting that TT can be safely administered to appropriate patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone therapy does not increase the risks of prostate cancer recurrence or death after definitive treatment for localized disease. Sarkar, RR., Patel, SH., Parsons, JK., et al.[2021]

A systematic review of 21 studies found no significant association between testosterone replacement therapy (TRT) and biochemical recurrence (BCR) in prostate cancer patients who underwent definitive local therapy, with a pooled BCR rate of only 0.01.

Subgroup analyses showed similar results, with BCR rates of 0.00 for radical prostatectomy patients and 0.02 for those treated with other local therapies, suggesting that TRT may be safe for nonmetastatic prostate cancer patients post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological safety of testosterone replacement therapy in prostate cancer survivors after definitive local therapy: A systematic literature review and meta-analysis. Kardoust Parizi, M., Abufaraj, M., Fajkovic, H., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4709428/

Testosterone Replacement Therapy and Prostate Cancer ... Rhoden and Morgentaler [29] reported outcomes in 20 men with PIN on testosterone supplementation. After one year of therapy, they reported no change in PSA.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666168324002143

Prostate Cancer Oncologic Outcomes of Testosterone ... We found that testosterone therapy did not increase the risk of proceeding to active therapy or of death from prostate cancer.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813293

Prostate Safety Events During Testosterone Replacement ... The study's findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e24045

Testosterone replacement therapy (TRT) in patients with ... TRT can alleviate symptoms and improve metabolic outcomes. Contrary to longstanding concerns, there is no substantial evidence of increased ...

5. wjmh.org wjmh.org/DOIx.php?id=10.5534/wjmh.250086

Testosterone Replacement Therapy in Hypogonadal Men ... The results revealed no significant association between TRT and overall prostate cancer risk (OR 1.03; 95% CI 0.90–1.17). However, TRT was ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38150256/

Prostate Safety Events During Testosterone Replacement ... The effect of testosterone replacement therapy (TRT) on the risk of prostate cancer and other adverse prostate events is unknown.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125001683

Clinical Trial Protocol: Impact of Testosterone Replacement ... Some concerns remain that TRT increases the risk of prostate cancer recurrence. The results of this trial may provide answers about the benefits ...

8. cureus.com cureus.com/articles/421242-testosterone-replacement-in-prostate-carcinoma-a-systematic-review-of-an-emerging-paradigm-and-therapeutic-potential

Testosterone Replacement in Prostate Carcinoma No correlation between testosterone replacement therapy and prostate carcinoma exists, and TRT is not contraindicated in men post-definitive ...