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Trial record 1 of 6 for:    bhr pharma
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Maintaining Suppression of Testosterone With Transdermal Estradiol Gel (MASTERS)

This study has been terminated.
(Inability to recruit patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02349386
First Posted: January 28, 2015
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
H2O Clinical LLC
Q Squared Solutions, LLC
Information provided by (Responsible Party):
BHR Pharma, LLC
  Purpose
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.

Condition Intervention Phase
Cancer of the Prostate Drug: BHR-200 (0.36% transdermal 17β-estradiol gel) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of BHR-200 (0.36% Transdermal Estradiol Gel) for the Maintenance of Testosterone Suppression in Men With Advanced Androgen-Sensitive Prostate Cancer

Resource links provided by NLM:


Further study details as provided by BHR Pharma, LLC:

Primary Outcome Measures:
  • testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12. [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • testosterone suppression, defined as the absence of any T level over 50 ng/dL during Weeks 4-24. [ Time Frame: Week 24 ]
  • Incidence and severity of adverse events with special attention given to thromboembolic events. [ Time Frame: Week 24 ]
  • Serum concentrations of: follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone binding globulin (SHBG), and prostate-specific antigen (PSA). [ Time Frame: Week 24 ]

Enrollment: 34
Actual Study Start Date: July 2015
Estimated Study Completion Date: December 2018
Primary Completion Date: June 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
Other Name: BHR-200
Experimental: 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.
Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
Other Name: BHR-200
Experimental: 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.
Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
Other Name: BHR-200
Placebo Comparator: Placebo
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Drug: Placebo
An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349386


Locations
United States, Arizona
Urological Associates of Southern Arizona
Tucson, Arizona, United States, 85741
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
United States, Iowa
Adult Pediatric Urology, PC
Council Bluffs, Iowa, United States, 51501
United States, Nebraska
Adult Pediatric Urology, PC
Omaha, Nebraska, United States, 68114
United States, New Jersey
Delaware Valley Urology
Voorhees, New Jersey, United States, 08043
United States, New Mexico
AccumetRX Clinical Trials
Albuquerque, New Mexico, United States, 87109
United States, New York
Associated Medical Professionals of NY (AMP of NY)
Syracuse, New York, United States, 13210
United States, North Carolina
Eastern Urological Associates
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Urologic Consultants of Southeastern Pennsylvania (UCSEPA)
Bala-Cynwyd, Pennsylvania, United States, 19044
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
BHR Pharma, LLC
H2O Clinical LLC
Q Squared Solutions, LLC
Investigators
Study Director: Roland Gerritsen van der Hoop, MD, PhD BHR Pharma, LLC
  More Information

Publications:
Ockrim JL, Lalani EN, Laniado ME, Carter SS, Abel PD. Transdermal estradiol therapy for advanced prostate cancer--forward to the past? J Urol. 2003 May;169(5):1735-7.
Ockrim JL, Lalani el-N, Kakkar AK, Abel PD. Transdermal estradiol therapy for prostate cancer reduces thrombophilic activation and protects against thromboembolism. J Urol. 2005 Aug;174(2):527-33; discussion 532-3.
Ockrim JL, Abel PD. Long term androgen deprivation therapy in prostate cancer. BMJ. 2008 Sep 22;337:a1361. doi: 10.1136/bmj.a1361.
Ockrim J, Lalani el-N, Abel P. Therapy Insight: parenteral estrogen treatment for prostate cancer--a new dawn for an old therapy. Nat Clin Pract Oncol. 2006 Oct;3(10):552-63. Review.
Langley RE, Godsland IF, Kynaston H, Clarke NW, Rosen SD, Morgan RC, Pollock P, Kockelbergh R, Lalani el-N, Dearnaley D, Parmar M, Abel PD. Early hormonal data from a multicentre phase II trial using transdermal oestrogen patches as first-line hormonal therapy in patients with locally advanced or metastatic prostate cancer. BJU Int. 2008 Aug;102(4):442-5. doi: 10.1111/j.1464-410X.2008.07583.x. Epub 2008 Apr 16.
Langley RE, Cafferty FH, Alhasso AA, Rosen SD, Sundaram SK, Freeman SC, Pollock P, Jinks RC, Godsland IF, Kockelbergh R, Clarke NW, Kynaston HG, Parmar MK, Abel PD. Cardiovascular outcomes in patients with locally advanced and metastatic prostate cancer treated with luteinising-hormone-releasing-hormone agonists or transdermal oestrogen: the randomised, phase 2 MRC PATCH trial (PR09). Lancet Oncol. 2013 Apr;14(4):306-16. doi: 10.1016/S1470-2045(13)70025-1. Epub 2013 Mar 4.
Bland LB, Garzotto M, DeLoughery TG, Ryan CW, Schuff KG, Wersinger EM, Lemmon D, Beer TM. Phase II study of transdermal estradiol in androgen-independent prostate carcinoma. Cancer. 2005 Feb 15;103(4):717-23.
Cox RL, Crawford ED. Estrogens in the treatment of prostate cancer. J Urol. 1995 Dec;154(6):1991-8. Review.
Lycette JL, Bland LB, Garzotto M, Beer TM. Parenteral estrogens for prostate cancer: can a new route of administration overcome old toxicities? Clin Genitourin Cancer. 2006 Dec;5(3):198-205. Review.
Sayed Y, Taxel P. The use of estrogen therapy in men. Curr Opin Pharmacol. 2003 Dec;3(6):650-4. Review.

Responsible Party: BHR Pharma, LLC
ClinicalTrials.gov Identifier: NCT02349386     History of Changes
Other Study ID Numbers: BHR-200-201
First Submitted: January 23, 2015
First Posted: January 28, 2015
Last Update Posted: July 13, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Methyltestosterone
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female


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