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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

Short name BAT

NCTNCT01750398 (opens ClinicalTrials.gov in a new tab)Other idJ1298Other idNA_00077460

Overview

Status
Completed
Phase
Phase 2
Enrollment
33 participants (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2013
Primary completion
Jun 2015
Completion
Jun 2015
First posted
17 Dec 2012 (estimated)
Last update posted
5 Dec 2016 (estimated)
Conditions
Recurrent Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 2

    BAT

    NCT01750398

    Jan 2013 to Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Testosterone cypionateDrug
  • GoserelinDrug
  • LeuprolideDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Patients With PSA <4 ng/mL at the End of the Study

    Time frame · 18 months

    Registry description

    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 outcomes(6)
  1. Radiographic or Clinical Progression

    Time frame · 18 months

    Registry description

    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).

  2. Complete PSA Response

    Time frame · 18 months

    Registry description

    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

  3. Change in C-telopeptides

    Time frame · 6 months and 9 months

    Registry description

    Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)

  4. Quality of Life Survey

    Time frame · 3 months

    Registry description

    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.

  5. Change in Weight

    Time frame · Baseline, 6 months and 9 months.

    Registry description

    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).

  6. Change in Waist Circumference

    Time frame · Bseline, 6 months and 9 months.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 18 months

Patients With PSA <4 ng/mL at the End of the Study

GroupValue (participants)
ADT Plus IM Testosterone17
Secondary and other outcome results(6)
Secondary outcomeNumber· 18 months

Radiographic or Clinical Progression

GroupValue (participants)
ADT Plus IM Testosterone6
Secondary outcomeNumber· 18 months

Complete PSA Response

GroupValue (participants)
ADT Plus IM Testosterone3
Secondary outcomeMean· 6 months and 9 months

Change in C-telopeptides

GroupValue (pg/ml)Spread
ADT Plus IM Testosterone-159.77190.66
Secondary outcomeMedian· 3 months

Quality of Life Survey

GroupValue (units on a scale)
ADT Plus IM Testosterone3.2
Secondary outcomeMean· Baseline, 6 months and 9 months.

Change in Weight

GroupValue (kg)Spread
ADT Plus IM Testosterone2.084.99
Secondary outcomeMean· Bseline, 6 months and 9 months.

Change in Waist Circumference

GroupValue (cm)Spread
ADT Plus IM Testosterone3.911.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ADT Plus IM TestosteroneMen 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. 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. Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an "LHRH agonist." Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.–0 / 2923 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedDenmeade S, Lim SJ, Isaaccson Velho P, Wang H. PSA provocation by bipolar androgen therapy may predict duration of response to first-line androgen deprivation: Updated results from the BATMAN study. Prostate. 2022 Dec;82(16):1529-1536. doi: 10.1002/pros.24426. Epub 2022 Aug 8. PMID 35938545

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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