Trial Outcomes & Findings for Bipolar Androgen-based Therapy for Prostate Cancer (BAT) (NCT NCT01750398)
NCT ID: NCT01750398
Last Updated: 2016-12-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
18 months
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
ADT Plus IM 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.
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.
|
|---|---|
|
ADT Lead In Phase
STARTED
|
33
|
|
ADT Lead In Phase
COMPLETED
|
29
|
|
ADT Lead In Phase
NOT COMPLETED
|
4
|
|
Bipolar Androgen Thearpy Phase
STARTED
|
29
|
|
Bipolar Androgen Thearpy Phase
COMPLETED
|
26
|
|
Bipolar Androgen Thearpy Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bipolar Androgen-based Therapy for Prostate Cancer (BAT)
Baseline characteristics by cohort
| Measure |
ADT Plus IM Testosterone
n=33 Participants
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.
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.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
PSA
|
27.6 ng/mL
n=5 Participants
|
|
PSA doubling time
|
5 months
n=5 Participants
|
|
Gleason score (higher score is associated with worse outcomes)
Gleason 6
|
3 Number of patients
n=5 Participants
|
|
Gleason score (higher score is associated with worse outcomes)
Gleason 7
|
16 Number of patients
n=5 Participants
|
|
Gleason score (higher score is associated with worse outcomes)
Gleason 8
|
5 Number of patients
n=5 Participants
|
|
Gleason score (higher score is associated with worse outcomes)
Gleason 9
|
9 Number of patients
n=5 Participants
|
|
Local treatment
No local treatment
|
3 Number of patients
n=5 Participants
|
|
Local treatment
Radiation
|
8 Number of patients
n=5 Participants
|
|
Local treatment
Radical prostatectomy
|
22 Number of patients
n=5 Participants
|
|
ECOG
ECOG 0
|
31 Number of patients
n=5 Participants
|
|
ECOG
ECOG 1
|
2 Number of patients
n=5 Participants
|
|
Any metastatic disease
Positive for metastases
|
20 Number of patients
n=5 Participants
|
|
Any metastatic disease
No metastases
|
13 Number of patients
n=5 Participants
|
|
Patients with bone metastases
No bone metastases
|
19 Number of patients
n=5 Participants
|
|
Patients with bone metastases
Positive for bone metastases
|
14 Number of patients
n=5 Participants
|
|
Patients with RECIST evaluable disease
No RECIST evaluable lesions
|
20 Number of patients
n=5 Participants
|
|
Patients with RECIST evaluable disease
Positive for RECIST evaluable lesions
|
13 Number of patients
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsTo 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.
Outcome measures
| Measure |
ADT Plus IM Testosterone
n=29 Participants
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.
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.
|
|---|---|
|
Patients With PSA <4 ng/mL at the End of the Study
|
17 participants
Interval 12.0 to 21.0
|
SECONDARY outcome
Timeframe: 18 monthsTo 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).
Outcome measures
| Measure |
ADT Plus IM Testosterone
n=29 Participants
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.
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.
|
|---|---|
|
Radiographic or Clinical Progression
Patients with radiographic/clinical progression
|
6 participants
|
|
Radiographic or Clinical Progression
Patients without radiographic/clinical progression
|
23 participants
|
SECONDARY outcome
Timeframe: 18 monthsTo 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
Outcome measures
| Measure |
ADT Plus IM Testosterone
n=29 Participants
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.
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.
|
|---|---|
|
Complete PSA Response
Patients with PSA <0.2 ng/ml
|
3 participants
|
|
Complete PSA Response
Patients with PSA ≥0.2 ng/ml
|
26 participants
|
SECONDARY outcome
Timeframe: 6 months and 9 monthsChange in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)
Outcome measures
| Measure |
ADT Plus IM Testosterone
n=33 Participants
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.
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.
|
|---|---|
|
Change in C-telopeptides
|
-159.77 pg/ml
Standard Deviation 190.66
|
SECONDARY outcome
Timeframe: 3 monthsTo 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.
Outcome measures
| Measure |
ADT Plus IM Testosterone
n=33 Participants
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.
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.
|
|---|---|
|
Quality of Life Survey
Change in SF-36 after round 1 of BAT
|
3.2 units on a scale
Interval -20.0 to 48.0
|
|
Quality of Life Survey
Change in IIEF after round 1 of BAT
|
10 units on a scale
Interval -4.0 to 59.0
|
|
Quality of Life Survey
Change in IPSS after round 1 of BAT
|
0 units on a scale
Interval -9.0 to 8.0
|
|
Quality of Life Survey
Change in FACT-P after round 1 of BAT
|
3.5 units on a scale
Interval -30.0 to 50.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
ADT Plus IM Testosterone
n=33 Participants
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.
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.
|
|---|---|
|
Change in Weight
Following ADT lead in
|
2.08 kg
Standard Deviation 4.99
|
|
Change in Weight
Following round 1 of BAT
|
1.21 kg
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Bseline, 6 months and 9 months.Outcome measures
| Measure |
ADT Plus IM Testosterone
n=33 Participants
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.
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.
|
|---|---|
|
Change in Waist Circumference
Following ADT lead in
|
3.9 cm
Standard Deviation 11.7
|
|
Change in Waist Circumference
Following round 1 of BAT
|
-1.09 cm
Standard Deviation 1.54
|
Adverse Events
ADT Plus IM Testosterone
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADT Plus IM Testosterone
n=29 participants at risk
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.
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.
|
|---|---|
|
Endocrine disorders
Hot flashes
|
51.7%
15/29 • 18 months
|
|
Blood and lymphatic system disorders
Edema
|
37.9%
11/29 • 18 months
|
|
Metabolism and nutrition disorders
Weight gain
|
13.8%
4/29 • 18 months
|
|
General disorders
Fatigue
|
10.3%
3/29 • 18 months
|
|
General disorders
Pain
|
6.9%
2/29 • 18 months
|
|
Renal and urinary disorders
Hematuria
|
6.9%
2/29 • 18 months
|
|
Ear and labyrinth disorders
Tinnitus
|
3.4%
1/29 • 18 months
|
|
Psychiatric disorders
Mood changes
|
3.4%
1/29 • 18 months
|
|
General disorders
Loss of libido
|
3.4%
1/29 • 18 months
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • 18 months
|
|
Cardiac disorders
Palpitations
|
3.4%
1/29 • 18 months
|
|
Skin and subcutaneous tissue disorders
Facial flushing
|
3.4%
1/29 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea with exertion
|
3.4%
1/29 • 18 months
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place