Related Experiment Video
Updated: Jun 15, 2026
09:21
Serum and Plasma Copy Number Detection Using Real-time PCR
Published on: December 15, 2017
11.7K
TRANSFORMER: A Randomized Phase II Study Comparing Bipolar Androgen Therapy Versus Enzalutamide in Asymptomatic Men
Samuel R Denmeade1, Hao Wang1, Neeraj Agarwal2
1The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Summary
Bipolar androgen therapy (BAT) shows clinical activity in castration-resistant prostate cancer (CRPC) and improves quality of life. Sequential therapy with BAT and enzalutamide may enhance outcomes in CRPC patients.
Area of Science:
- Oncology
- Urology
- Endocrinology
Background:
- Prostate cancer (PCa) resistance to androgen ablation arises from adaptive upregulation of the androgen receptor.
- Bipolar androgen therapy (BAT) disrupts this adaptive regulation in castration-resistant PCa (CRPC) by cycling testosterone levels.
Purpose of the Study:
- To compare the efficacy and safety of monthly BAT versus enzalutamide in patients with CRPC.
- To evaluate the impact of BAT on progression-free survival (PFS), overall survival (OS), prostate-specific antigen (PSA) response, and quality of life (QoL).
Main Methods:
- The randomized TRANSFORMER study compared monthly BAT (n=94) with enzalutamide (n=101).
- Primary endpoint was PFS; crossover at progression was permitted.
- Secondary endpoints included OS, PSA response, PFS2, safety, and QoL.
Main Results:
- PFS was similar between arms (5.7 months).
- PSA50 response rates were comparable initially, but sequential BAT to enzalutamide improved PSA-PFS (10.9 months) and PFS2 (28.2 months).
- Quality of life consistently favored BAT, with primarily grade 1-2 adverse events.
Conclusions:
- BAT demonstrates meaningful clinical activity and safety in CRPC.
- BAT may sensitize CRPC to subsequent antiandrogen therapy.
- Further research is needed to optimize BAT integration and confirm survival benefits of sequential therapy.
