Patients With PSA <4 ng/mL at the End of the Study
| Group | Value (participants) |
|---|---|
| ADT Plus IM Testosterone | 17 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name BAT
United States
1 trial · 1 completed · 1 with posted results
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.
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.
Outcomes the sponsor listed as primary.
Patients With PSA <4 ng/mL at the End of the Study
Time frame · 18 months
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
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
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
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
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.
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| ADT Plus IM Testosterone | 17 |
| Group | Value (participants) |
|---|---|
| ADT Plus IM Testosterone | 6 |
| Group | Value (participants) |
|---|---|
| ADT Plus IM Testosterone | 3 |
| Group | Value (pg/ml) | Spread |
|---|---|---|
| ADT Plus IM Testosterone | -159.77 | 190.66 |
| Group | Value (units on a scale) |
|---|---|
| ADT Plus IM Testosterone | 3.2 |
| Group | Value (kg) | Spread |
|---|---|---|
| ADT Plus IM Testosterone | 2.08 | 4.99 |
| Group | Value (cm) | Spread |
|---|---|---|
| ADT Plus IM Testosterone | 3.9 | 11.7 |
| Group | Deaths | Serious events | Other 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 / 29 | 23 / 29 |
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