Bipolar Androgen-based Therapy for Prostate Cancer (BAT) (BAT)
Recurrent Prostate Cancer
Drug: Testosterone cypionate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bipolar Androgen-based Therapy for Men With Androgen Ablation NaÃ-ve Recurrent Prostate Cancer|
- Patients With PSA <4 ng/mL at the End of the Study [ Time Frame: 18 months ] [ Designated as safety issue: No ]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.
- Radiographic or Clinical Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]To evaluate the number of men treated per the bipolar androgen therapy phase of the trial who developed radiographic or clinical progression. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was defined as new symptoms that can be attributed to progressive prostate cancer (e.g. new/worsening pain, urinary obstruction, cord compression, bone fractures).
- Complete PSA Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]To evaluate the number of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at the end of the study
- Change in C-telopeptides [ Time Frame: 6 months and 9 months ] [ Designated as safety issue: No ]Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)
- Quality of Life Survey [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To measure quality of life through the RAND-SF36 (short-form 36 questionnaire) Quality of Life Survey, the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale. Note that for all scales, higher scores indicate better quality of life/function, with the exception being the visual pain scale, where a higher score indicates more pain.
RAND-SF36: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Range is from 0 to 100.
FACT-P: A tool used for assessing the health-related quality of life in men with prostate cancer. Range is from 0 to 156.
IIEF: Is a measure of erectile function. Range is from 5 to 25. IPSS: A tool used to measure symptoms related to prostatic disease. Range is from 0 to 35.
Visual pain scale: A tool used to track pain level. Range is from 0 to 10.
- Change in Weight [ Time Frame: Baseline, 6 months and 9 months. ] [ Designated as safety issue: No ]Change in weight is measured from baseline to 6 months (i.e. following ADT lead in) and from 6 months to 9 months (i.e. from post-ADT to the end of cycle 1 of BAT).
- Change in Waist Circumference [ Time Frame: Bseline, 6 months and 9 months. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: ADT plus IV testosterone
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
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.
Other Name: TestosteroneDrug: Goserelin
Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an "LHRH agonist."
Other Name: ZoladexDrug: Leuprolide
Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.
Other Name: Lupron Depot
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750398
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Samuel Denmeade, MD||Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center|