- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615120
Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer
March 3, 2021 updated by: GTx
Phase II, Open Label Study of the Effect of GTx-758 as Secondary Hormonal Therapy on Serum PSA and Serum Free Testosterone Levels in Men With Metastatic Castration Resistant Prostate Cancer Maintained on Androgen Deprivation Therapy
Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy.
This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Burbank, California, United States, 91505
- Urology Associates Medical Group
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Los Angeles, California, United States, 90073
- VA of Greater Los Angeles
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Los Angeles, California, United States, 90078
- Tower Urology
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San Bernardino, California, United States, 92404
- San Bernardino Urological Assoc.
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San Diego, California, United States, 92123
- Genesis Healthcare Partners
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Torrance, California, United States, 90505
- Urology Specialists of So. California
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Colorado
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Aurora, Colorado, United States, 80045
- Univ. of Colorado Cancer Center
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Connecticut
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Middlebury, Connecticut, United States, 06762
- Connecticut Clinical Research Center
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Florida
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Aventura, Florida, United States, 33180
- So. Florida Medical Research
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Miami, Florida, United States, 33145
- AMPM Research
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Saint Petersburg, Florida, United States, 33710
- Pinellas Urology
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Saint Petersburg, Florida, United States, 33710
- GTx Investigative Site
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Sarasota, Florida, United States, 34237
- Coastal Medical Center
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Indiana
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Greenwood, Indiana, United States, 46143
- Urology of Indiana
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Jeffersonville, Indiana, United States, 47130
- First Urology PSC
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Maryland
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Towson, Maryland, United States, 21204
- Chesapeake Urology Research Assoc.
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Montana
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Missoula, Montana, United States, 59808
- Five Valleys Urology
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New York
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Albany, New York, United States, 12208
- Urological Institute of NE New York
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Oneida, New York, United States, 13421
- AMP of NY
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Syracuse, New York, United States, 13210
- AMP of NY
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North Carolina
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Concord, North Carolina, United States, 28025
- Carolina Clinical Trials
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Ohio
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Cincinnati, Ohio, United States, 45212
- The Urology Group
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- UCSEPA
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Tennessee
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Memphis, Tennessee, United States, 38119
- West Clinic
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Virginia
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Virginia Beach, Virginia, United States, 23462
- Urology of Virginia
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Washington
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Seattle, Washington, United States, 98195
- Seattle Cancer Care Alliance, Univ. of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Be over age 18 years
- Be able to Communicate effectively with the study personnel
- Have histologically confirmed prostate cancer
- Have castration resistant prostate cancer patients with radiographic evidence of metastatic disease (T any - N any - MI)
- ECOG performance status of 0 to 2
- Have been treated with ADT (chemical or surgical) for at least 6 months
- Have a castrate level of serum total testosterone (< 50ng/dL)
- Have a history of serum PSA response on ADT. A serum PSA response is an undetectable level of serum PSA (≤ 0.2/mL) or at least a 90% reduction in serum PSA from the serum PSA value prior to the initiation of treatment to < 10ng/mL
- Have a rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2ng/mL or > 2 ng/mL and a 25% increase above the nadir from the ADT.
- Be continued on ADT throughout this study
- give written informed consent prior to any study specific procedures
- subjects must agree, if not already on anticoagulation therapy or aspirin, to take 81 mg aspirin daily throughout the duration of their participation in this study and for 30 days after completion of dosing with GTx-758.
- Subjects must agree to use acceptable methods of contraception:
- If their female partners are pregnant or lactating, acceptable methods of contraception from the time of the first administration of study medication until 3 months following administration of the last dose of study medication must be used. Acceptable methods are: condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azospermia), a condom with spermicidal foam/gel/film/cream/suppository should be used.
- If the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 3 months following administration of the last dose of study medication.Acceptable methods of contraception are as follows: condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/fil/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}.
- If the female partner has undergone documented tubal ligation (female sterilization), a barrier method {condom used with spermicidal foam/gel/film/cream/suppository} should be used
- If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method {condom with spermicidal foam/gel/film/cream/suppository} should also be used.
Exclusion Criteria:
- Known hypersensitivity or allergy to estrogen or estrogen like drugs
- Need for urgent chemotherapy, radiation therapy or surgical intervention for prostate cancer in the opinion of the investigator;
- Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Subjects with a personal history of abnormal blood clotting or thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and or pulmonary embolus (PE)).
Any subjects, as determined by a central laboratory, with
- a modified activated protein C reaction ratio ≤ 2.5 and a Factor V Leiden gene mutation,
- an antithrombin level below the lower limit of the normal range,
- an antiphospholipid antibody level that is indeterminate, positive, or outside the normal range,
- or a prothrombin gene mutation
- Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or history of atrial fibrillation
- The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, any subject with liver enzymes (ALT or AST) above 2 times the upper limit of normal, total bilirubin above 2 times the upper limit of normal, or serum creatinine above 1.5 times the upper limit of normal will NOT be admitted to the study.
- Received an investigational drug within a period of 90 days prior to the enrollment in the study.
- Received the study medication GTx-758 previously;
- Currently taking testosterone, testosterone like agents, 5a-reductase inhibitor (finasteride, dutasteride),or antiandrogens (bicalutamide, flutamide or nilutamide). Subjects taking a 5a-reductase inhibitor or one of these antiandrogens may be eligible if the subject undergoes a 6 week washout period after stopping therapy. The subject must have at least two rising serum PSA levels at least 2 weeks apart after therapy with these 5a-reductase inhibitor or these antiandrogens have been stopped (antiandrogen withdrawal)and complete the 6-week washout period to be eligible;
- Have previously taken or are currently taking diethylstilbestrol, other estrogens, abiraterone or ketoconazole or any other inhibitor of CYP17 (17a-hydroxylase/C17,20-lyase);
- Currently having radiation therapy to prostate for cancer control (radiation to bone to relieve pain is acceptable)
- Have previously taken or are currently taking enzalutamide;
- Have previously received cytotoxic chemotherapy for prostate cancer;
- Recent hospitalization (within 30 days of screening);
- Recent surgery (within 30 days of screening);
- Have taken body building or fertility supplements within 4 weeks of admission into the study;
- Have been previously diagnosed or treated for active cancer (other than prostate cancer or non-melanoma skin cancer)within the previous five years;
- Have a BMI > 35.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GTx-758 125mg
one GTx-758 tablet orally administered daily
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One 125 mg tablet once a day
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Experimental: GTx-758 250 mg
two GTx-758 tablets orally administered daily
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two 125 mg tablets once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decline in Serum PSA
Time Frame: 120 days
|
The percentage of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120)
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120 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2012
Primary Completion (Actual)
November 9, 2016
Study Completion (Actual)
November 9, 2016
Study Registration Dates
First Submitted
June 6, 2012
First Submitted That Met QC Criteria
June 7, 2012
First Posted (Estimate)
June 8, 2012
Study Record Updates
Last Update Posted (Actual)
March 24, 2021
Last Update Submitted That Met QC Criteria
March 3, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G200712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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