Bipolar Androgen Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Roswell Park Cancer Institute
Must be taking: Androgen ablative therapy
Disqualifiers: Brain metastases, Uncontrolled infection, Thromboembolic event, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had chemotherapy or radiotherapy within 4 weeks before starting the study, which might imply a need to pause certain treatments. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Bipolar Androgen Therapy (BAT) for prostate cancer?
Research shows that Bipolar Androgen Therapy (BAT) can be safely given to men with prostate cancer that no longer responds to standard hormone treatments. It has been found to reduce prostate-specific antigen (a marker of prostate cancer) levels and produce positive responses in 30%-40% of patients, and it may also help other treatments work better afterwards.
12345Is Bipolar Androgen Therapy (BAT) safe for humans?
Bipolar Androgen Therapy (BAT) has been shown to be safe in clinical studies for men with castration-resistant prostate cancer, with no serious adverse events reported.
12467How is Bipolar Androgen Therapy different from other treatments for prostate cancer?
Bipolar Androgen Therapy (BAT) is unique because it involves rapidly alternating testosterone levels between very high and very low, which is different from standard treatments that typically aim to lower testosterone. This approach can help resensitize cancer to other therapies and has shown promise in patients with castration-resistant prostate cancer.
12457Eligibility Criteria
This trial is for individuals with metastatic castration-resistant prostate cancer, which means their cancer has spread and doesn't respond to low testosterone levels. Participants should have a certain level of PSA in their blood and must not have received specific treatments before.Inclusion Criteria
Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]): ≤ 3 × institutional ULN
I am 18 years old or older.
+12 more
Exclusion Criteria
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
Unwilling or unable to follow protocol requirements
Evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive testosterone intramuscularly on day 1 of each cycle, with cycles repeating every 28 days for 3 cycles
12 weeks
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up at 30 days and every 3 months for up to 2 years
Up to 2 years
Multiple visits (in-person)
Participant Groups
The study tests bipolar androgen therapy (BAT) using testosterone to see if it can make the body's cells more sensitive again to hormone treatment. It involves alternating between very low and high testosterone levels, alongside standard care like scans and biopsies.
1Treatment groups
Experimental Treatment
Group I: Treatment (Bipolar androgen therapy)Experimental Treatment7 Interventions
Patients receive testosterone IM on day 1 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also continue to receive standard of care leuprolide acetate SC per their standard schedule. Patients undergo CT scan, bone scan and may undergo MRI and tumor biopsy throughout the study.
Bipolar Androgen Therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as Bipolar Androgen Therapy for:
- Metastatic Castration-Resistant Prostate Cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
Loading ...
Who Is Running the Clinical Trial?
Roswell Park Cancer InstituteLead Sponsor
References
Bipolar androgen therapy (BAT): A patient's guide. [2022]Bipolar androgen therapy (BAT) is a new treatment concept for men whose prostate cancer has become resistant to standard hormone-blocking therapy. Over the past decade, we have performed a series of clinical studies testing BAT in asymptomatic men with castration-resistant prostate cancer. The key findings from these clinical studies are that BAT (a) can be safely administered to asymptomatic patients with metastatic castrate-resistant prostate cancer; (b) does not produce symptomatic disease progression; (c) produces sustained prostate-specific antigen and objective responses in 30%-40% of patients; and (d) can resensitize and prolong response to subsequent antiandrogen therapy. The concept of BAT has generated significant interest from men with prostate cancer, their families, and their physicians. Here we provide a "Patient's Guide" that answers questions about BAT in a form that is accessible to patients, their families, and physicians. Our goal is to provide information to help patients make the most informed decisions they can regarding their prostate cancer treatment.
Bipolar Androgen Therapy: A Paradoxical Approach for the Treatment of Castration-resistant Prostate Cancer. [2019]Bipolar androgen therapy (BAT) is a paradoxical treatment for castrate-resistant prostate cancer whereby testosterone levels are rapidly alternated between supraphysiologic and near-castrate concentrations. Initial studies demonstrated that BAT is safe and produces clinical responses. A trial comparing enzalutamide against BAT is ongoing.
Bipolar androgen therapy in men with metastatic castration-resistant prostate cancer after progression on enzalutamide: an open-label, phase 2, multicohort study. [2021]Prostate cancer that progresses after enzalutamide treatment is poorly responsive to further antiandrogen therapy, and paradoxically, rapid cycling between high and low serum testosterone concentrations (bipolar androgen therapy [BAT]) in this setting might induce tumour responses. We aimed to evaluate BAT in patients with metastatic castration-resistant prostate cancer that progressed after enzalutamide.
[Bipolar androgen therapy: A novel therapeutic strategy for castration-resistant prostate cancer]. [2018]Bipolar androgen therapy (BAT), as a new therapeutic strategy for castration-resistant prostate cancer (CRPC), can significantly reduce the level of prostate-specific antigen (PSA) for prostate cancer patients and has exhibited an excellent safety profile with no serious adverse events. Based on the clinical trials recently published at home and abroad, this article reviews the background, action mechanism, development, and prospect of BAT.
Molecular and Clinical Characterization of Patients With Metastatic Castration Resistant Prostate Cancer Achieving Deep Responses to Bipolar Androgen Therapy. [2022]Bipolar androgen therapy (BAT) is an emerging treatment strategy for men with metastatic castration resistant prostate cancer (mCRPC) whereby serum testosterone is cycled from supraphysiologic to near-castrate levels each month. BAT has been shown to induce clinical responses in a significant proportion of patients, some of which are extreme. We explored the clinical and molecular characteristics of patients with mCRPC who achieved deep responses to BAT.
Efficacy and safety of bipolar androgen therapy in castration-resistant prostate cancer following abiraterone or enzalutamide resistance: A systematic review. [2023]Bipolar androgen therapy (BAT) is a new endocrinologic treatment for castration-resistant prostate cancer (CRPC) that can restore some patients' sensitivity to drugs such as abiraterone (Abi) and enzalutamide (Enz). We performed a meta-analysis using STATA16. Sensitivity analyses were performed by examining the effects of individual studies using different effect models and detecting any publication bias using the Harbord test. In a total of 108 unique records, ten studies were included in the final meta-analysis. Participants who underwent BAT achieved a PSA50 response rate of 27% (95%CI [0.22,0.31], I2=17.98%), ORR of 34% (95%CI [0.24,0.43], I2=0), and incidence of AEs (grade≥3) of 14% (95%CI [0.09,0.19], I2=0). Patients who completed BAT proceeded to AR-targeted therapy (Abi or Enz) and achieved a PSA50 response rate of 57% (95% CI [0.36,0.78], I2=0). Patients with prior Enz resistance had a stronger impact on the PSA50 of AR-target therapy rechallenge. The results of this meta-analysis indicate that BAT is a safe and effective treatment for patients who have progressed after Abi or Enz. BAT can trigger the resensitization of patients with CRPC to subsequent endocrine therapy and improve the overall survival of patients and their quality of life.
Bipolar androgen therapy plus olaparib in men with metastatic castration-resistant prostate cancer. [2023]Bipolar androgen therapy (BAT) results in rapid fluctuation of testosterone (T) between near-castrate and supraphysiological levels and has shown promise in metastatic castration-resistant prostate cancer (mCRPC). Its clinical effects may be mediated through induction of DNA damage, and preclinical studies suggest synergy with PARP inhibitors.