Cancer of the Prostate
Conditions
Brief summary
The objective of this clinical study is to evaluate the safety and efficacy of three different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate cancer.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, dose finding study in men with advanced androgen-sensitive prostate cancer. Patients who give informed consent will have screening evaluations, and if fulfilling the entry criteria, will be randomized to one of 4 treatment groups: 1mL, 2mL or 3mL of 0.36% BHR-200 (transdermal estradiol gel) or Placebo. Study drug will be initiated on the day they were scheduled to receive next depot GnRH agonist injection. Patients will be offered low-dose radiation to aid in the prevention of gynecomastia. Patients will apply the study drug once per day. The first dose of study gel will be applied under the supervision of the PI/designee. Subsequent doses will be self-administered daily by the patient until he is no longer chemically castrated (testosterone levels increase above 50 ng/dL), a rise over baseline PSA of \> 0.5 ng/mL is observed, or he has completed 52 weeks of study drug administration. At the conclusion of study participation, patients will be advised to resume standard of care treatment under the supervision of their healthcare provider. While on treatment, patients will be evaluated at Day 1 and every 2 weeks, for the first 24 weeks and every 4 weeks thereafter with a final post-treatment follow-up visit 2 weeks (+/- 1 week) post last dose administration.
Interventions
DRUGBHR-200 (0.36% transdermal 17β-estradiol gel)
An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
DRUGPlacebo
An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
Sponsors
H2O Clinical LLC
Q2 Solutions
BHR Pharma, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males, Ages 18 and older 2. Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) 3. Not currently hospitalized 4. Clinical indication of adenocarcinoma of the prostate evidenced by a biopsy report on record 5. At present receiving ADT treatment with a GnRH agonist for at least 2 months but not longer than 36 months without interruption - Note: If the patient received GnRH agonist treatment prior to the treatment described under 5, there must be evidence of a period without GnRH agonist treatment for a minimum of 2 months prior to starting the present treatment as is seen, for example with intermittent treatment regimens. 6. Able to initiate Screening procedures 2 weeks prior to the next scheduled injection with a GnRH agonist 7. Willing to discontinue current ADT regimen for the duration of the study 8. T level less than 50 ng/dL at Screening 9. WHO/ECOG performance status of 0 or 1 10. Life expectancy of at least 1 year 11. Adequate renal function demonstrated by having normal blood urea nitrogen (BUN) and Creatinine Screening lab values
Exclusion criteria
1. History or presence of allergic or adverse response to estradiol 2. Presence of symptomatic metastatic disease, risk of spinal cord compression or urinary obstruction 3. History within the past 2 years of deep vein thrombosis (DVT), pulmonary embolism (PE2), a known thrombophilic disorder (eg.protein C, protein S, or antithrombin deficiency), or cerebrovascular accident (CVA) 4. History within the past 2 years of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft) 5. History of congestive heart failure 6. Use of any investigational drug, biologic, or device within 28 days prior to the first dose of study gel 7. Use of any of the following known inducers or inhibitors of cytochrome P450 3A4 (CYP3A4): phenobarbital, carbamazepine, rifampin, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, St. John's Wort preparations (Hypericum perforatum), and grapefruit juice 8. Hematological parameters (Hematocrit or Hemoglobin) outside 20% of the upper or lower limits of normal at Screening 9. Active skin rash, sunburn, or other skin disorder on the upper arm(s) that requires treatment or may affect skin absorption of study gel 10. Resting uncontrolled hypertension (HTN) (160/100 mmHg) at Screening 11. Co-existent malignancy or a history of malignancy during the past 5 years, with the exception of basal and/or squamous cell carcinoma of the skin 12. Any other significant concurrent illness or disease or condition that in the opinion of the Investigator might interfere with the patient's ability to receive the treatment outlined in the protocol or might put him at additional risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Testosterone Suppression at Week 12 | Week 12 | Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Testosterone Suppression at Week 24 | Week 24 | Pproportion of patients failing to maintaincastrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 24. |
| Number of Patients Reporting Thromboembolic Adverse Events | To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study | Number of patients and severity of thromboembolic adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Follicle-stimulating Hormone (FSH) | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 | Serum concentrations of follicle-stimulating hormone (FSH) |
| Luteinizing Hormone (LH) | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 | Serum concentrations of luteinizing hormone (LH) |
| Maintenance of Testosterone Suppression at Week 52/ End of Study | Double-blind 28-Week Optional Extension Study from Week 24 to Week 52/End of Study | Proportion of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 24 to 52/End of Study |
| Sex Hormone Binding Globulin (SHBG) | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 | Serum concentrations of sex hormone binding globulin (SHBG) |
| Prostate Specific Antigen (PSA) | To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study | Serum concentrations of prostate specific antigen (PSA) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BHR-200 Low Dose 3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. | 9 |
| BHR-200 Mid Dose 6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. | 8 |
| BHR-200 High Dose 9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. | 9 |
| Placebo 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. | 8 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 24-Week Double-Blind Main Study | Adverse Event | 0 | 0 | 1 | 1 |
| 24-Week Double-Blind Main Study | Lack of Efficacy | 6 | 6 | 2 | 7 |
| 24-Week Double-Blind Main Study | Patient underwent transurethral resection of prostate (exclusionary procedure) | 0 | 0 | 1 | 0 |
| 24-Week Double-Blind Main Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
| 28-Week Double-Blind Optional Extension | Lack of Efficacy | 2 | 0 | 2 | 0 |
| 28-Week Double-Blind Optional Extension | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | BHR-200 Low Dose | BHR-200 Mid Dose | BHR-200 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 8 Participants | 7 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 5 Participants | 8 Participants | 7 Participants | 26 Participants |
| Region of Enrollment United States | 9 participants | 8 participants | 9 participants | 8 participants | 34 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 9 Participants | 8 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 7 / 9 | 5 / 8 | 9 / 9 | 4 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 | 2 / 9 | 0 / 8 |
Outcome results
Primary
Maintenance of Testosterone Suppression at Week 12
Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12.
Time frame: Week 12
Population: The Intent-to-treat (ITT) population contains all patients who are randomized into the study. All efficacy parameters were analyzed using the ITT population. In the case of a patient who was randomized but did not take the study drug, the analysis was done for this patient using the randomized treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BHR-200 Low Dose | Maintenance of Testosterone Suppression at Week 12 | 3 Participants |
| BHR-200 Mid Dose | Maintenance of Testosterone Suppression at Week 12 | 3 Participants |
| BHR-200 High Dose | Maintenance of Testosterone Suppression at Week 12 | 5 Participants |
| Placebo | Maintenance of Testosterone Suppression at Week 12 | 2 Participants |
Secondary
Maintenance of Testosterone Suppression at Week 24
Pproportion of patients failing to maintaincastrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 24.
Time frame: Week 24
Population: The Intent-to-treat (ITT) population contains all patients who are randomized into the study. All efficacy parameters were analyzed using the ITT population. In the case of a patient who was randomized but did not take the study drug, the analysis was done for this patient using the randomized treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BHR-200 Low Dose | Maintenance of Testosterone Suppression at Week 24 | 3 Participants |
| BHR-200 Mid Dose | Maintenance of Testosterone Suppression at Week 24 | 2 Participants |
| BHR-200 High Dose | Maintenance of Testosterone Suppression at Week 24 | 3 Participants |
| Placebo | Maintenance of Testosterone Suppression at Week 24 | 0 Participants |
Secondary
Number of Patients Reporting Thromboembolic Adverse Events
Number of patients and severity of thromboembolic adverse events
Time frame: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BHR-200 Low Dose | Number of Patients Reporting Thromboembolic Adverse Events | 0 Participants |
| BHR-200 Mid Dose | Number of Patients Reporting Thromboembolic Adverse Events | 0 Participants |
| BHR-200 High Dose | Number of Patients Reporting Thromboembolic Adverse Events | 0 Participants |
| Placebo | Number of Patients Reporting Thromboembolic Adverse Events | 0 Participants |
Other Pre-specified
Follicle-stimulating Hormone (FSH)
Serum concentrations of follicle-stimulating hormone (FSH)
Time frame: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Safety population: contains all patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BHR-200 Low Dose | Follicle-stimulating Hormone (FSH) | Week 36 FSH | 2.050 IU/L | Standard Deviation 1.3435 |
| BHR-200 Low Dose | Follicle-stimulating Hormone (FSH) | Week 24 FSH | 1.600 IU/L | Standard Deviation 0.9165 |
| BHR-200 Low Dose | Follicle-stimulating Hormone (FSH) | Week 12 FSH | 0.630 IU/L | Standard Deviation 0.2339 |
| BHR-200 Low Dose | Follicle-stimulating Hormone (FSH) | Baseline FSH | 4.478 IU/L | Standard Deviation 1.9911 |
| BHR-200 Low Dose | Follicle-stimulating Hormone (FSH) | Week 48 FSH | 2.00 IU/L | Standard Deviation 0 |
| BHR-200 Mid Dose | Follicle-stimulating Hormone (FSH) | Week 12 FSH | 0.493 IU/L | Standard Deviation 0.0058 |
| BHR-200 Mid Dose | Follicle-stimulating Hormone (FSH) | Week 24 FSH | 0.795 IU/L | Standard Deviation 0.4313 |
| BHR-200 Mid Dose | Follicle-stimulating Hormone (FSH) | Baseline FSH | 5.225 IU/L | Standard Deviation 1.8093 |
| BHR-200 Mid Dose | Follicle-stimulating Hormone (FSH) | Week 36 FSH | 1.095 IU/L | Standard Deviation 0.8556 |
| BHR-200 Mid Dose | Follicle-stimulating Hormone (FSH) | Week 48 FSH | 0.795 IU/L | Standard Deviation 0.4313 |
| BHR-200 High Dose | Follicle-stimulating Hormone (FSH) | Week 36 FSH | 10.600 IU/L | Standard Deviation 12.7279 |
| BHR-200 High Dose | Follicle-stimulating Hormone (FSH) | Baseline FSH | 3.963 IU/L | Standard Deviation 2.1354 |
| BHR-200 High Dose | Follicle-stimulating Hormone (FSH) | Week 48 FSH | 1.500 IU/L | Standard Deviation 0 |
| BHR-200 High Dose | Follicle-stimulating Hormone (FSH) | Week 24 FSH | 0.848 IU/L | Standard Deviation 0.5219 |
| BHR-200 High Dose | Follicle-stimulating Hormone (FSH) | Week 12 FSH | 3.848 IU/L | Standard Deviation 5.0343 |
| Placebo | Follicle-stimulating Hormone (FSH) | Week 12 FSH | 9.450 IU/L | Standard Deviation 5.4447 |
| Placebo | Follicle-stimulating Hormone (FSH) | Baseline FSH | 5.700 IU/L | Standard Deviation 2.0901 |
Other Pre-specified
Luteinizing Hormone (LH)
Serum concentrations of luteinizing hormone (LH)
Time frame: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Safety population: contains all patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BHR-200 Low Dose | Luteinizing Hormone (LH) | Baseline LH | 0.380 IU/L | Standard Deviation 0.57 |
| BHR-200 Low Dose | Luteinizing Hormone (LH) | Week 12 LH | 0.227 IU/L | Standard Deviation 0.0635 |
| BHR-200 Low Dose | Luteinizing Hormone (LH) | Week 24 LH | 0.997 IU/L | Standard Deviation 0.7267 |
| BHR-200 Low Dose | Luteinizing Hormone (LH) | Week 36 LH | 0.645 IU/L | Standard Deviation 0.6435 |
| BHR-200 Low Dose | Luteinizing Hormone (LH) | Week 48 LH | 0.600 IU/L | Standard Deviation 0 |
| BHR-200 Mid Dose | Luteinizing Hormone (LH) | Week 12 LH | 0.527 IU/L | Standard Deviation 0.5831 |
| BHR-200 Mid Dose | Luteinizing Hormone (LH) | Week 24 LH | 0.395 IU/L | Standard Deviation 0.2899 |
| BHR-200 Mid Dose | Luteinizing Hormone (LH) | Week 48 LH | 0.300 IU/L | Standard Deviation 0.1414 |
| BHR-200 Mid Dose | Luteinizing Hormone (LH) | Week 36 LH | 0.345 IU/L | Standard Deviation 0.2192 |
| BHR-200 Mid Dose | Luteinizing Hormone (LH) | Baseline LH | 0.470 IU/L | Standard Deviation 0.5949 |
| BHR-200 High Dose | Luteinizing Hormone (LH) | Week 12 LH | 1.597 IU/L | Standard Deviation 2.1889 |
| BHR-200 High Dose | Luteinizing Hormone (LH) | Baseline LH | 0.190 IU/L | Standard Deviation 0 |
| BHR-200 High Dose | Luteinizing Hormone (LH) | Week 48 LH | 0.300 IU/L | Standard Deviation 0 |
| BHR-200 High Dose | Luteinizing Hormone (LH) | Week 36 LH | 3.750 IU/L | Standard Deviation 4.7376 |
| BHR-200 High Dose | Luteinizing Hormone (LH) | Week 24 LH | 0.393 IU/L | Standard Deviation 0.405 |
| Placebo | Luteinizing Hormone (LH) | Baseline LH | 0.530 IU/L | Standard Deviation 0.9576 |
| Placebo | Luteinizing Hormone (LH) | Week 12 LH | 2.050 IU/L | Standard Deviation 2.192 |
Other Pre-specified
Maintenance of Testosterone Suppression at Week 52/ End of Study
Proportion of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 24 to 52/End of Study
Time frame: Double-blind 28-Week Optional Extension Study from Week 24 to Week 52/End of Study
Population: Intent-to-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BHR-200 Low Dose | Maintenance of Testosterone Suppression at Week 52/ End of Study | 1 Participants |
| BHR-200 Mid Dose | Maintenance of Testosterone Suppression at Week 52/ End of Study | 2 Participants |
| BHR-200 High Dose | Maintenance of Testosterone Suppression at Week 52/ End of Study | 2 Participants |
| Placebo | Maintenance of Testosterone Suppression at Week 52/ End of Study | 0 Participants |
Other Pre-specified
Prostate Specific Antigen (PSA)
Serum concentrations of prostate specific antigen (PSA)
Time frame: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study
Population: Safety population: contains all patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 40 PSA | 0.750 ng/ML | Standard Deviation 0.2121 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 32 PSA | 0.463 ng/ML | Standard Deviation 0.3272 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 28 PSA | 0.430 ng/ML | Standard Deviation 0.311 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 24 PSA | 0.363 ng/ML | Standard Deviation 0.3099 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 16 PSA | 0.297 ng/ML | Standard Deviation 0.2684 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 52 PSA | 0.700 ng/ML | Standard Deviation 0 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 20 PSA | 0.330 ng/ML | Standard Deviation 0.3251 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 48 PSA | 0.700 ng/ML | Standard Deviation 0 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 4 PSA | 0.459 ng/ML | Standard Deviation 0.6234 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Baseline PSA | 0.374 ng/ML | Standard Deviation 0.4572 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 44 PSA | 0.500 ng/ML | Standard Deviation 0 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 12 PSA | 0.330 ng/ML | Standard Deviation 0.3251 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 8 PSA | 0.545 ng/ML | Standard Deviation 0.7978 |
| BHR-200 Low Dose | Prostate Specific Antigen (PSA) | Week 36 PSA | 0.650 ng/ML | Standard Deviation 0.0707 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 40 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 12 PSA | 0.227 ng/ML | Standard Deviation 0.2367 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 36 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Baseline PSA | 0.921 ng/ML | Standard Deviation 1.1726 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 4 PSA | 1.483 ng/ML | Standard Deviation 2.2501 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 8 PSA | 1.145 ng/ML | Standard Deviation 1.6158 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 16 PSA | 0.160 ng/ML | Standard Deviation 0.1212 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 20 PSA | 0.127 ng/ML | Standard Deviation 0.0635 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 24 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 28 PSA | 0.090 ng/ML | Standard Deviation 0 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 32 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 44 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 48 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 Mid Dose | Prostate Specific Antigen (PSA) | Week 52 PSA | 0.145 ng/ML | Standard Deviation 0.0778 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 24 PSA | 4.745 ng/ML | Standard Deviation 9.3033 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 52 PSA | 13.300 ng/ML | Standard Deviation 0 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 28 PSA | 4.863 ng/ML | Standard Deviation 8.259 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Baseline PSA | 8.058 ng/ML | Standard Deviation 22.2814 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 16 PSA | 6.960 ng/ML | Standard Deviation 11.8992 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 44 PSA | 12.600 ng/ML | Standard Deviation 0 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 20 PSA | 5.345 ng/ML | Standard Deviation 10.5033 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 12 PSA | 4.380 ng/ML | Standard Deviation 10.4936 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 48 PSA | 12.800 ng/ML | Standard Deviation 0 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 32 PSA | 4.563 ng/ML | Standard Deviation 7.7394 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 36 PSA | 7.050 ng/ML | Standard Deviation 9.5459 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 8 PSA | 4.995 ng/ML | Standard Deviation 12.005 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 40 PSA | 7.800 ng/ML | Standard Deviation 0 |
| BHR-200 High Dose | Prostate Specific Antigen (PSA) | Week 4 PSA | 5.170 ng/ML | Standard Deviation 13.1114 |
| Placebo | Prostate Specific Antigen (PSA) | Week 8 PSA | 0.870 ng/ML | Standard Deviation 0.9449 |
| Placebo | Prostate Specific Antigen (PSA) | Week 4 PSA | 0.481 ng/ML | Standard Deviation 0.6153 |
| Placebo | Prostate Specific Antigen (PSA) | Week 16 PSA | 0.090 ng/ML | Standard Deviation 0 |
| Placebo | Prostate Specific Antigen (PSA) | Baseline PSA | 0.334 ng/ML | Standard Deviation 0.5623 |
| Placebo | Prostate Specific Antigen (PSA) | Week 12 PSA | 1.395 ng/ML | Standard Deviation 1.8455 |
Other Pre-specified
Sex Hormone Binding Globulin (SHBG)
Serum concentrations of sex hormone binding globulin (SHBG)
Time frame: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Safety population: contains all patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BHR-200 Low Dose | Sex Hormone Binding Globulin (SHBG) | Baseline SHBG | 49.7 nmol/L | Standard Deviation 17.65 |
| BHR-200 Low Dose | Sex Hormone Binding Globulin (SHBG) | Week 12 SHBG | 48.7 nmol/L | Standard Deviation 18.01 |
| BHR-200 Low Dose | Sex Hormone Binding Globulin (SHBG) | Week 24 SHBG | 50.3 nmol/L | Standard Deviation 15.63 |
| BHR-200 Low Dose | Sex Hormone Binding Globulin (SHBG) | Week 36 SHBG | 37.0 nmol/L | Standard Deviation 7.07 |
| BHR-200 Low Dose | Sex Hormone Binding Globulin (SHBG) | Week 48 SHBG | 46.0 nmol/L | Standard Deviation 0 |
| BHR-200 Mid Dose | Sex Hormone Binding Globulin (SHBG) | Week 12 SHBG | 55.7 nmol/L | Standard Deviation 3.06 |
| BHR-200 Mid Dose | Sex Hormone Binding Globulin (SHBG) | Week 24 SHBG | 52.0 nmol/L | Standard Deviation 4.24 |
| BHR-200 Mid Dose | Sex Hormone Binding Globulin (SHBG) | Week 48 SHBG | 42.5 nmol/L | Standard Deviation 7.78 |
| BHR-200 Mid Dose | Sex Hormone Binding Globulin (SHBG) | Week 36 SHBG | 53.5 nmol/L | Standard Deviation 3.54 |
| BHR-200 Mid Dose | Sex Hormone Binding Globulin (SHBG) | Baseline SHBG | 52.8 nmol/L | Standard Deviation 22.48 |
| BHR-200 High Dose | Sex Hormone Binding Globulin (SHBG) | Week 12 SHBG | 55.2 nmol/L | Standard Deviation 10.62 |
| BHR-200 High Dose | Sex Hormone Binding Globulin (SHBG) | Baseline SHBG | 45.8 nmol/L | Standard Deviation 15.64 |
| BHR-200 High Dose | Sex Hormone Binding Globulin (SHBG) | Week 48 SHBG | 58.0 nmol/L | Standard Deviation 0 |
| BHR-200 High Dose | Sex Hormone Binding Globulin (SHBG) | Week 36 SHBG | 47.0 nmol/L | Standard Deviation 12.73 |
| BHR-200 High Dose | Sex Hormone Binding Globulin (SHBG) | Week 24 SHBG | 71.3 nmol/L | Standard Deviation 8.62 |
| Placebo | Sex Hormone Binding Globulin (SHBG) | Baseline SHBG | 48.8 nmol/L | Standard Deviation 24.09 |
| Placebo | Sex Hormone Binding Globulin (SHBG) | Week 12 SHBG | 27.0 nmol/L | Standard Deviation 2.83 |