Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

Completed · Phase 2

Conditions studied: Recurrent Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01750398

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

33

Starts

2013-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-12-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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