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Prostate CancerPhase 2NCT01615120

Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer

A Phase 2 study testing GTx-758 125 mg and GTx-758 250 mg in people with Prostate Cancer, run by GTx at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
GTx-758 125 mg and GTx-758 250 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
26 sitesUnited States
Study dates
14 Aug 2012to 9 Nov 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Urological Institute of NE New York

    Albany, New York, 12208

  • Univ. of Colorado Cancer Center

    Aurora, Colorado, 80045

  • So. Florida Medical Research

    Aventura, Florida, 33180

  • UCSEPA

    Bala-Cynwyd, Pennsylvania, 19004

  • Urology Associates Medical Group

    Burbank, California, 91505

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Carolina Clinical Trials

    Concord, North Carolina, 28025

  • Urology of Indiana

    Greenwood, Indiana, 46143

  • First Urology PSC

    Jeffersonville, Indiana, 47130

  • VA of Greater Los Angeles

    Los Angeles, California, 90073

  • Tower Urology

    Los Angeles, California, 90078

  • West Clinic

    Memphis, Tennessee, 38119

  • AMPM Research

    Miami, Florida, 33145

  • Connecticut Clinical Research Center

    Middlebury, Connecticut, 06762

  • Five Valleys Urology

    Missoula, Montana, 59808

  • AMP of NY

    Oneida, New York, 13421

  • San Bernardino Urological Assoc.

    San Bernardino, California, 92404

  • Genesis Healthcare Partners

    San Diego, California, 92123

  • Coastal Medical Center

    Sarasota, Florida, 34237

  • Seattle Cancer Care Alliance, Univ. of Washington

    Seattle, Washington, 98195

  • GTx Investigative Site

    St. Petersburg, Florida, 33710

  • Pinellas Urology

    St. Petersburg, Florida, 33710

  • AMP of NY

    Syracuse, New York, 13210

  • Urology Specialists of So. California

    Torrance, California, 90505

  • Chesapeake Urology Research Assoc.

    Towson, Maryland, 21204

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

Other trials in United States

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
GTx-758 125 mg, GTx-758 250 mg
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GTx-758 125 mgDrug

    One 125 mg tablet once a day

  • GTx-758 250 mgDrug

    two 125 mg tablets once daily

Study groups in NCT01615120
Study groupRoleWhat they receive
GTx-758 125mgExperimentalone GTx-758 tablet orally administered daily
Receives: Drug: GTx-758 125 mg
GTx-758 250 mgExperimentaltwo GTx-758 tablets orally administered daily
Receives: Drug: GTx-758 250 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decline in Serum PSA

    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)

    Measured: 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2012 (estimated)
  2. Study start14 Aug 2012
  3. Primary completion9 Nov 2016
  4. Study completion9 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01615120
Sponsor's protocol ID
G200712
Status last verified
Mar 2021
First submitted
6 Jun 2012
Last updated
24 Mar 2021
Data monitoring committee
Yes

Publications

  • Yu EY, Getzenberg RH, Coss CC, Gittelman MM, Keane T, Tutrone R, Belkoff L, Given R, Bass J, Chu F, Gambla M, Gaylis F, Bailen J, Hancock ML, Smith J, Dalton JT, Steiner MS. Selective estrogen receptor alpha agonist GTx-758 decreases testosterone with reduced side effects of androgen deprivation therapy in men with advanced prostate cancer. Eur Urol. 2015 Feb;67(2):334-41. doi: 10.1016/j.eururo.2014.06.011. Epub 2014 Jun 24.

    PubMed 24968970

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GTx-758 125 mg and GTx-758 250 mg in people with Prostate Cancer, run by GTx at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decline in Serum PSA (time frame: 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01615120, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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