Who is sponsoring NCT02286921?

NCT02286921 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT02286921?

Interventions in NCT02286921: Testosterone cypionate, Enzalutamide, Testosterone Enanthate.

What condition does NCT02286921 study?

NCT02286921 studies Castration Resistant Metastatic Prostate Cancer.

Is NCT02286921 still recruiting?

NCT02286921 is currently completed. Last updated 9 October 2020.

Are results published for NCT02286921?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-09 · How we verify

NCT02286921: Transformer

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer

Completed Phase 2 Results posted Last updated 9 October 2020

What this trial tests

Phase 2 trial testing Testosterone cypionate in Castration Resistant Metastatic Prostate Cancer in 222 participants. Completed in 21 February 2020.

Timeline

1 January 2015

Primary endpoint
26 October 2018

21 February 2020

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	222
Start date	1 January 2015
Primary completion	26 October 2018
Estimated completion	21 February 2020
Sites	17 locations across United States

Drugs / interventions tested

Testosterone cypionate — full drug profile →
Enzalutamide (enzalutamide) — full drug profile →
Testosterone Enanthate — full drug profile →

Conditions studied

Castration Resistant Metastatic Prostate Cancer — all drugs for Castration Resistant Metastatic Prostate Cancer →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 80, male only, with Castration Resistant Metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression
Time frame: up to 2 years
Time to clinical progression will be defined as months from randomization to any of the following (whichever occurs earlier): * Cancer pain requiring initiation of chronic administration of opiate analgesia (oral opiate use for ≥3 weeks; parenteral opiate use for ≥7 days. Patients with cancer pain requiring opiate analgesia for relief should also be assessed by the investigator for the need for i

Sponsor's own description

Asymptomatic men with progressive metastatic Castration-resistant prostate cancer (CRPC) post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels \[i.e. Bipolar Androgen Therapy (BAT)\] will improve primary and secondary objectives vs. enzalutamide as standard therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Androgen receptor variant-driven prostate cancer: clinical implications and therapeutic targeting.
Antonarakis ES, Armstrong AJ, Dehm SM, Luo J. · · 2016 · cited 144× · PMID 27184811 · DOI 10.1038/pcan.2016.17
TRANSFORMER: A Randomized Phase II Study Comparing Bipolar Androgen Therapy Versus Enzalutamide in Asymptomatic Men With Castration-Resistant Metastatic Prostate Cancer.
Denmeade SR, Wang H, Agarwal N, Smith DC, et al · · 2021 · cited 106× · PMID 33617303 · DOI 10.1200/jco.20.02759
Supraphysiological androgens suppress prostate cancer growth through androgen receptor-mediated DNA damage.
Chatterjee P, Schweizer MT, Lucas JM, Coleman I, et al · · 2019 · cited 89× · PMID 31310591 · DOI 10.1172/jci127613
Enzalutamide-resistant castration-resistant prostate cancer: challenges and solutions.
Tucci M, Zichi C, Buttigliero C, Vignani F, et al · · 2018 · cited 62× · PMID 30425524 · DOI 10.2147/ott.s153764
Androgen pathway resistance in prostate cancer and therapeutic implications.
Maughan BL, Antonarakis ES. · · 2015 · cited 49× · PMID 26067250 · DOI 10.1517/14656566.2015.1055249
AR Splicing Variants and Resistance to AR Targeting Agents.
Kanayama M, Lu C, Luo J, Antonarakis ES, et al · · 2021 · cited 43× · PMID 34071114 · DOI 10.3390/cancers13112563
The testosterone paradox of advanced prostate cancer: mechanistic insights and clinical implications.
Kumar R, Sena LA, Denmeade SR, Kachhap S. · · 2023 · cited 38× · PMID 36543976 · DOI 10.1038/s41585-022-00686-y
Supraphysiologic Testosterone Therapy in the Treatment of Prostate Cancer: Models, Mechanisms and Questions.
Mohammad OS, Nyquist MD, Schweizer MT, Balk SP, et al · · 2017 · cited 32× · PMID 29210989 · DOI 10.3390/cancers9120166

Verify or expand the search:

Other trials of Testosterone cypionate

Trials testing the same drug.

NCT07278362 — Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance · Phase 4 · not yet recruiting
NCT07142551 — Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response · Phase 2 · recruiting
NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC) · Phase 2 · recruiting
NCT06111209 — The Anabolic Effect of Testosterone on Pelvic Floor Muscles · Phase 2 · recruiting
NCT04424654 — Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy · Phase 2 · completed

Other recruiting trials for Castration Resistant Metastatic Prostate Cancer

Currently open trials in the same condition.

NCT07038304 — The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC) · Phase 2 · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02286921 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 9 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02286921.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing