Prostate CancerPhase 2GTx758NCT01326312
Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
A Phase 2 study testing GTx-758 1000mg, Lupron Depot and GTx-758 2000mg in people with Prostate Cancer, run by GTx at 36 sites in United States.
Trial summary
The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GTx-758 1000mg, Lupron Depot and GTx-758 2000mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 36 sitesUnited States
- Study dates
- Jun 2011to Dec 2012
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be between age 45 and 80 years of age
- be able to communicate effectively with study personnel
- ECOG is < or = 2
- screening serum total testosterone> or = 150ng/dL
- have prostate cancer, confirmed by pathology report
- have not been treated with androgen deprivation therapy(chemical or surgical
Show all 9Show fewer
- have a clinical indication for the initiation of androgen deprivation therapy
- give written informed consent prior to any study specific procedures
- subject must agree to use acceptable methods of contraception
Who cannot join
- known hypersensitivity or allergy to estrogen or estrogen like drugs
- a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
- history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease
- have ALT or AST above 2 times the upper normal limit
- have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline
- patients cannot have brain or spinal cord metastases
Show all 15Show fewer
- patients cannot have or be at risk for spinal cord compression from bone metastases
- received an investigational drug within a period of 90 days prior to enrollment in the study
- received the study medication previously
- currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization
- currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization)
- have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization
- have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements)
- have a history of cancer other than prostate cancer, superficial bladder cancer (with no recurrence in the last 5 years) and/or non-melanoma carcinoma of the skin
- QTcB>480 msec, If the first QTcB reading exceeds 480msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB or readings to determine if the subject satisfies the above criteria. If the average QYcB reading is >480 msec then the subject is excluded.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
GTx Investigative Site
Albany, New York, 12208
GTx Investigative Site
Albuquerque, New Mexico, 87109
GTx Investigative Site
Annapolis, Maryland, 21401
GTx Investigative Site
Arlington, Texas, 76017
GTx Investigative Site
Aventura, Florida, 33180
GTx Investigative Site
Bala-Cynwyd, Pennsylvania, 19004
GTx Investigative Site
Baltimore, Maryland, 21204
GTx Investigative Site
Brick, New Jersey, 08724
GTx Investigative Site
Chapel Hill, North Carolina, 27514
GTx Investigative Site
Cincinnati, Ohio, 45212
GTx Investigative Site
Columbus, Ohio, 43220
GTx Investigative Site
Daytona Beach, Florida, 32114
GTx Investigative Site
Fort Wayne, Indiana, 46825
GTx Investigative Site
Garden City, New York, 11530
GTx Investigative Site
Houston, Texas, 77030
GTx Investigative Site
Indianapolis, Indiana, 46260
GTx Investigative Site
Jeffersonville, Indiana, 47130
GTx Investigative Site
La Mesa, California, 91942
GTx Investigative Site
Lancaster, Pennsylvania, 17606
GTx Investigative Site
Lawrenceville, New Jersey, 08648
GTx Investigative Site
Los Angeles, California, 90048
GTx Investigative Site
Marietta, Georgia, 30060
GTx Investigative Site
Memphis, Tennessee, 38117
GTx Investigative Site
Middlebury, Connecticut, 06762
GTx Investigative Site
Myrtle Beach, South Carolina, 29572
GTx Investigative Site
Nashville, Tennessee, 37209
GTx Investigative Site
New York, New York, 10016
GTx Investigative Site
Oneida, New York, 13421
GTx Investigative Site
Phoenix, Arizona, 85032
GTx Investigative Site
Pittsburgh, Pennsylvania, 15232
GTx Investigative Site
Raleigh, North Carolina, 27607
GTx Investigative Site
San Antonio, Texas, 78229
GTx Investigative Site
San Bernardino, California, 92404
GTx Investigative Site
Springfield, Illinois, 62703
GTx Investigative Site
Syracuse, New York, 13210
GTx Investigative Site
Wellington, Florida, 33449
About this study
Official title: Phase II, Open Label, Dose Finding Study of the Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer Compared to a Luteinizing Hormone Releasing Hormone Agonist
The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.
Read the detailed description
Prostate cancer is one of the most frequently diagnosed noncutaneous cancers among men in the US and is the second most common cause of cancer deaths. Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy. ADT by LHRH agonists, LHRH antagonists, or bilateral orchiectomy not only reduces testosterone, but also substantially lowers estrogen levels as estrogen is derived from the aromatization of testosterone. ADT-induced estrogen deficiency causes significant side effects which include hot flushes, gynecomastia, bone loss, decreases in bone quality and strength, osteoporosis and life-threatening fractures, adverse lipid changes, increase in body fat composition, and higher cardiovascular disease and myocardial infarction, and depression and other mood changes.
GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone. However, because it is a selective ER agonist, GTx-758 may maintain bone, does not induce hot flushes, avoids adverse lipid changes and body fat composition changes, and does not have the acute testosterone surge that are associated with other forms of ADT.
- Conditions
- Prostate Cancer
- Being tested
- GTx-758 1000mg, Lupron Depot, GTx-758 2000mg
- 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 1000mgDrug
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Lupron DepotDrug
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
GTx-758 2000mgDrug
comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
| Study group | Role | What they receive |
|---|---|---|
| GTx- 758 1000mg | Experimental | GTx-758/Experimental/ nonsteroidal selective ER alpha agonist Receives: Drug: GTx-758 2000mg |
| GTx-758 2000mg | Experimental | GTx-758/Experimental/ nonsteroidal selective ER alpha agonist Receives: Drug: GTx-758 1000mg |
| Lupron Depot | Active comparator | Luteinizing Hormone Releasing Hormone Agonist Receives: Drug: Lupron Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Are Castrate by Day 60
Measured: 60 days
Secondary outcomes (2)
Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.
Measured: 12 months
Time to Castration in Participants With Prostate Cancer
Median time to castration was summarized using the Kaplan-Meier method.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: FDA Clinical Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Steiner, MD, Study director, GTx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326312
- Sponsor's protocol ID
- G200705
- Acronym
- GTx758
- Status last verified
- Feb 2021
- First submitted
- 25 Mar 2011
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label, Dose Finding Study of the Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer Compared to a Luteinizing Hormone Releasing Hormone Agonist
- ClinicalTrials.gov ID
- NCT01326312
- Acronym / sponsor ID
- GTx758 / G200705
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA Clinical Hold
- Enrolment
- 159 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.
Detailed description
Prostate cancer is one of the most frequently diagnosed noncutaneous cancers among men in the US and is the second most common cause of cancer deaths. Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy. ADT by LHRH agonists, LHRH antagonists, or bilateral orchiectomy not only reduces testosterone, but also substantially lowers estrogen levels as estrogen is derived from the aromatization of testosterone. ADT-induced estrogen deficiency causes significant side effects which include hot flushes, gynecomastia, bone loss, decreases in bone quality and strength, osteoporosis and life-threatening fractures, adverse lipid changes, increase in body fat composition, and higher cardiovascular disease and myocardial infarction, and depression and other mood changes.
GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone. However, because it is a selective ER agonist, GTx-758 may maintain bone, does not induce hot flushes, avoids adverse lipid changes and body fat composition changes, and does not have the acute testosterone surge that are associated with other forms of ADT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GTx- 758 1000mg | Experimental | Drug: GTx-758 2000mgGTx-758/Experimental/ nonsteroidal selective ER alpha agonist |
| GTx-758 2000mg | Experimental | Drug: GTx-758 1000mgGTx-758/Experimental/ nonsteroidal selective ER alpha agonist |
| Lupron Depot | Active comparator | Drug: Lupron DepotLuteinizing Hormone Releasing Hormone Agonist |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be between age 45 and 80 years of age
- be able to communicate effectively with study personnel
- ECOG is < or = 2
- screening serum total testosterone> or = 150ng/dL
- have prostate cancer, confirmed by pathology report
Key exclusion criteria (15 listed)
- known hypersensitivity or allergy to estrogen or estrogen like drugs
- a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
- history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease
- have ALT or AST above 2 times the upper normal limit
- have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTx-758 1000mgcomparison of different dosages of GTx-758 with leuprolide acetate for depot suspension | Drug | GTx-758 2000mg |
| Lupron Depotcomparison of different dosages of GTx-758 with leuprolide acetate for depot suspension | Drug | Lupron Depot |
| GTx-758 2000mgcomparison of different dosages of GTx-758 with leuprolide acetate for depot suspension | Drug | GTx- 758 1000mg |
Primary outcome
Number of Participants Who Are Castrate by Day 60
Time frame: 60 days
2 secondary outcomes
Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.
Time frame: 12 months
Time to Castration in Participants With Prostate Cancer
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Steiner, MD study director
GTx
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTx-758 1000mg, Lupron Depot and GTx-758 2000mg in people with Prostate Cancer, run by GTx at 36 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 22 Jun 2023). 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?
Number of Participants Who Are Castrate by Day 60 (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.