Bipolar Androgen-based Therapy for Prostate Cancer (BAT)
This study is currently recruiting participants.
Verified November 2013 by Sidney Kimmel Comprehensive Cancer Center
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
First received: December 12, 2012
Last updated: November 7, 2013
Last verified: November 2013
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.
Recurrent Prostate Cancer
Drug: Testosterone cypionate
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Bipolar Androgen-based Therapy for Men With Androgen Ablation NaÃ-ve Recurrent Prostate Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
- Radiographic or clinical progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate percent with radiographic or clinical progression
- complete PSA response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate percent of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml)
- The safety of alternating parenteral testosterone and androgen deprivation therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To investigate the safety of alternating parenteral testosterone and androgen deprivation therapy in men with recurrent or newly metastatic prostate cancer. Safety will be evaluated by the incidence, severity, duration, causality, seriousness, and type(s) of adverse events as assessed by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.
- Correlative metabolic studies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate correlative metabolic studies including: bone densitometry, lipid panel, adiponectin, serum testosterone, insulin, fasting glucose, hemoglobin A1c, leptin, TSH, fibrinogen, C-reactive protein, and serum c-telopeptides, body weight, body mass index (BMI), lean mass, fat mass, waist circumference and blood pressure
- Quality of Life Survey [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To measure quality of life through the RAND-SF36 Quality of Life Survey, the FACT-P, the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
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: Testosterone
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750398
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
|Baltimore, Maryland, United States, 21231 |
|Contact: Avery Spitz, RN 410-502-2043 firstname.lastname@example.org |
|Contact: Michael Schweizer, MD 410-955-8893 email@example.com |
|Principal Investigator: Samuel Denmeade, MD |
Sidney Kimmel Comprehensive Cancer Center
||Samuel Denmeade, MD
||Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
No publications provided
||Sidney Kimmel Comprehensive Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 12, 2012
||November 7, 2013
||United States: Institutional Review Board
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Testosterone, Leuprolide, Goserelin
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal