Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01750398
First received: December 12, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Prostate Cancer
Drug: Testosterone cypionate
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • The clinical effects of BAT [ Time Frame: 2 years ] [ 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 PSA response.


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: 33
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Performance status ≤2.
  3. Documented histologically confirmed adenocarcinoma of the prostate.
  4. 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).
  5. No prior treatment with second line hormonal therapies (flutamide, bicalutamide, nilutamide, ketoconazole, abiraterone acetate or MDV3100) is permitted.
  6. 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
  7. No prior treatment with chemotherapeutic regimens allowed.
  8. Prior treatment with non-hormonal investigational agents is permitted.
  9. Evidence of rising PSA on two successive dates > 2 weeks apart. There is no maximum or minimum PSA requirement to come on study.
  10. 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
  11. Patient may have lymph node metastases with no single lymph node >5 cm short axis diameter
  12. Patients must be asymptomatic with no sites of pain due to prostate cancer.

Exclusion Criteria:

  1. 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.
  2. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  3. 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).
  4. 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).
  5. No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study
  6. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
  7. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  8. 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
  9. Inability to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750398

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Samuel Denmeade, MD Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01750398     History of Changes
Other Study ID Numbers: J1298, NA_00077460
Study First Received: December 12, 2012
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Testosterone, Leuprolide, Goserelin

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Androgens
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014