Sam Denmeade (Johns Hopkins) again [1] (12/28/20). Seems familiar, though.
BAT: "29 patients with CRPC received first-line hormonal therapy with 400 mg of testosterone cypionate intramuscularly every 28 days concurrent with a luteinising hormone-releasing hormone agonist/antagonist."
"After treatment with BAT, four of 29 patients (14% ...) experienced a PSA50 response.
"The median radiographic progression-free survival to BAT was 8.5 months ... for patients with metastatic CRPC.
"After progression on BAT, 17 of 18 patients ... achieved a PSA50 response and 15 of 18 patients ... achieved a PSA90 response on abiraterone or enzalutamide.
"Twelve of 15 patients ... with metastatic CRPC remain on abiraterone or enzalutamide with a median duration of follow-up of 11.2 months."
{I'm still waiting for the BAT study to prevent CRPC. BAT after CRPC is never going to work for everyone.}
-Patrick
[1] pubmed.ncbi.nlm.nih.gov/333...
Eur J Cancer
. 2020 Dec 28;144:302-309. doi: 10.1016/j.ejca.2020.11.043. Online ahead of print.
Bipolar androgen therapy sensitizes castration-resistant prostate cancer to subsequent androgen receptor ablative therapy
Laura A Sena 1 , Hao Wang 1 , Su J Lim ScM 1 , Irina Rifkind 1 , Nduku Ngomba 1 , John T Isaacs 1 , Jun Luo 1 , Caroline Pratz 1 , Victoria Sinibaldi 1 , Michael A Carducci 1 , Channing J Paller 1 , Mario A Eisenberger 1 , Mark C Markowski 1 , Emmanuel S Antonarakis 1 , Samuel R Denmeade 2
Affiliations collapse
Affiliations
1 The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
2 The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: denmesa@jhmi.edu.
PMID: 33383350 DOI: 10.1016/j.ejca.2020.11.043
Abstract
Background: Cyclical, high-dose testosterone administration, termed bipolar androgen therapy (BAT), can induce clinical responses and restore sensitivity to androgen signalling inhibition in patients with previously treated castration-resistant prostate cancer (PCa) (CRPC). This trial evaluated whether BAT is a safe and effective first-line hormonal therapy for patients with CRPC.
Patients and methods: In cohort C of this single-centre, open-label, phase II, multi-cohort trial (RE-sensitizing with Supraphysiologic Testosterone to Overcome REsistance study), 29 patients with CRPC received first-line hormonal therapy with 400 mg of testosterone cypionate intramuscularly every 28 days concurrent with a luteinising hormone-releasing hormone agonist/antagonist. The primary end-point of the study was the PSA50 response rate to BAT treatment.
Results: After treatment with BAT, four of 29 patients (14%; 95% confidence interval [CI]: 4-32%) experienced a PSA50 response. The median radiographic progression-free survival to BAT was 8.5 months (95% CI: 6.9-15.1) for patients with metastatic CRPC. After progression on BAT, 17 of 18 patients (94%; 95% CI: 73-100%) achieved a PSA50 response and 15 of 18 patients (83%; 95% CI: 59-96) achieved a PSA90 response on abiraterone or enzalutamide. Twelve of 15 patients (80%; 95% CI: 52-96) with metastatic CRPC remain on abiraterone or enzalutamide with a median duration of follow-up of 11.2 months.
Conclusion: As first-line hormonal treatment for CRPC, BAT was well tolerated and resulted in prolonged disease stabilisation. After progression on BAT, patients had favourable responses to second-generation androgen receptor-targeted therapy.
Trial registration: ClinicalTrials.gov NCT02090114.
Keywords: Bipolar androgen therapy; Castration-resistant prostate cancer; RESTORE trial; Testosterone.
Copyright © 2020 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Conflict of interest statement E.S.A. reports being a paid consultant/advisor to Janssen, Astellas, Sanofi, Dendreon, Pfizer, Amgen, Lilly, Bayer, AstraZeneca, Bristol-Myers Squibb, Clovis and Merck; reports receiving research funding to his institution from Janssen, Johnson & Johnson, Sanofi, Dendreon, Genentech, Novartis, Tokai, Bristol Myers-Squibb, AstraZeneca, Clovis, and Merck and he reports being the co-inventor of an AR-V7 biomarker technology that has been licenced to Qiagen.