Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

NCT01750398 | Completed Phase 2 Results DMC

• 2 other identifiers: J1298NA_00077460
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and clinical effects of alternating androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer as first line hormonal therapy, to assess the effect of alternating therapy on quality of life and metabolic changes associated with androgen-deprivation therapy.

Conditions

Recurrent Prostate Cancer

Keywords

Testosterone, Leuprolide, Goserelin

Outcome Measures

Primary Outcomes (1)

• Patients With PSA <4 ng/mL at the End of the Study

  To determine the clinical effects of BAT in men with recurrent prostate cancer as first line therapy. This will be accomplished by assessing the number of patients achieving a PSA \<4 ng/ml at the end of the trial.

  18 months

Secondary Outcomes (6)

• Radiographic or Clinical Progression

  18 months

• Complete PSA Response

  18 months

• Change in C-telopeptides

  6 months and 9 months

• Quality of Life Survey

  3 months

• Change in Weight

  Baseline, 6 months and 9 months.

Study Arms (1)

ADT plus IV testosterone

EXPERIMENTAL

Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial "lead-in" castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.

Drug: Testosterone cypionate; Drug: Goserelin; Drug: Leuprolide

Interventions

Testosterone cypionate DRUG

DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.

Also known as: Testosterone

ADT plus IV testosterone

Goserelin DRUG

Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an "LHRH agonist."

Also known as: Zoladex

ADT plus IV testosterone

Leuprolide DRUG

Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.

Also known as: Lupron Depot

ADT plus IV testosterone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Performance status ≤2.
• Documented histologically confirmed adenocarcinoma of the prostate.
• No prior AD therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for recurrent or metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive local therapy if it was administered ≥ 1 year prior to recurrence).
• No prior treatment with second line hormonal therapies (flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone acetate or MDV3100) is permitted.
• Prior treatment with 5-alpha reductase inhibitors (e.g. finasteride or dutasteride) for treatment of benign prostatic hyperplasia (BPH) is permitted, but patients must be off therapy for ≥ 6 months prior to enrolling on study
• No prior treatment with chemotherapeutic regimens allowed.
• Prior treatment with non-hormonal investigational agents is permitted.
• Evidence of rising PSA on two successive dates \> 2 weeks apart. There is no maximum or minimum PSA requirement to come on study.
• Patients must have ≤ 10 total sites of bone metastases and no evidence for lung or liver or other parenchymal metastases documented within 28 days of enrollment on trial
• Patient may have lymph node metastases with no single lymph node \>5 cm short axis diameter
• Patients must be asymptomatic with no sites of pain due to prostate cancer.

You may not qualify if:

• 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.
• Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
• Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction).
• Requires urinary catheterization for voiding as a result of tumor obstructing the urinary outflow tract; catheterization is permitted if due to a non-oncologic cause (e.g urethral stricture or atonic bladder).
• No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study
• Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
• Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
• Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within 5 years prior to enrollment in the study
• Inability to provide informed consent.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

• Denmeade S, Lim SJ, Isaaccson Velho P, Wang H. PSA provocation by bipolar androgen therapy may predict duration of response to first-line androgen deprivation: Updated results from the BATMAN study. Prostate. 2022 Dec;82(16):1529-1536. doi: 10.1002/pros.24426. Epub 2022 Aug 8.

  PMID: 35938545 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

testosterone 17 beta-cypionate; Testosterone; Goserelin; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Samuel Denmeade
• Organization: SKCCC at Johns Hopkins

denmesa@jhmi.edu

410-955-8875

Study Officials

• Samuel Denmeade, MD

  Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)