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Bipolar Androgen-based Therapy for Prostate Cancer (BAT) (BAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01750398
First received: December 12, 2012
Last updated: October 10, 2016
Last verified: October 2016
  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
Drug: Goserelin
Drug: Leuprolide
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:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Testosterone
Drug: Goserelin
Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an "LHRH agonist."
Other Name: Zoladex
Drug: Leuprolide
Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.
Other Name: Lupron Depot

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
Results First Received: June 29, 2016
Last Updated: October 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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
Goserelin
Leuprolide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on December 09, 2016