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

Trial Summary

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 data supports the effectiveness of the treatment Therapeutic Testosterone for prostate cancer?

Research suggests that testosterone replacement therapy (TRT) may be safe for certain men with prostate cancer, especially those who have been treated with curative intent and have no active disease. While there are concerns about cancer growth, some studies indicate TRT can be cautiously considered in specific low-risk cases. ^{1 2 3 4 5}

Is testosterone replacement therapy safe for prostate cancer patients?

Research suggests that testosterone replacement therapy (TRT) can be cautiously considered for some prostate cancer patients, especially those with low-risk or treated conditions, without increasing the risk of cancer recurrence or death. However, TRT may enhance existing prostate cancer, so careful monitoring is essential. ^{1 4 6 7 8}

How is testosterone replacement therapy different for prostate cancer treatment?

Testosterone replacement therapy for prostate cancer is unique because it challenges the traditional belief that testosterone fuels cancer growth. Recent evidence suggests it may be safe and beneficial for men with prostate cancer who have low testosterone levels, potentially improving their quality of life. ^{2 4 5 6 9}

What is the purpose of this trial?

This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.

Research Team

Ahmed Aly

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

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]

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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy in Men with Untreated or Treated Prostate Cancer: Do We Have Enough Evidences? [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of androgen therapy in men with prostate cancer. [2022]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Hypogonadism in Low-Risk Prostate Cancer Survivors. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Testosterone replacement therapy in patients with prostate cancer after radical prostatectomy. [2021]

6. Germany 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Testosterone therapy does not increase the risks of prostate cancer recurrence or death after definitive treatment for localized disease. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Androgen replacement therapy and prostate safety. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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