Prostate CancerPhase 2NCT01420861

GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer

A Phase 2 study testing GTx-758 in people with Prostate Cancer, run by GTx at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on androgen deprivation therapy (Serum PSA response and Serum PSA progression) Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: GTx-758
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 7 sitesUnited States
Study dates: Sep 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 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Be over 18 years of age
Be able to communicate effectively with the study personnel
Have histologically confirmed prostate cancer
ECOG performance status of 0 to 2
Have been treated with ADT(chemical or surgical) for at least 6 months
Have castrate level of serum total testosterone (<50 ng/dL)

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Have a history of serum PSA response after initiation of ADT, serum PSA response is at least a 90% reduction in serum PSA to <10 ng/mL OR undetectable level of serum PSA (less tan or =0.2 ng/mL)
Have rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2 ng/mL or 2ng/mL and a 25% increase over the nadir after the initiation of ADT
Be continued on androgen deprivation therapy throughout this study
Give written informed consent prior to any study specific procedures
Subjects must agree to use acceptable methods of contraception:
oIf 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. oIf 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/film/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}. oIf the female partner has undergone documented tubal ligation (female sterilization), a barrier method {condom used with spermicidal foam/gel/film/cream/suppository} should also be used. oIf the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and 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;
Have symptomatic metastatic prostate cancer
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;
History of abnormal blood clotting, Factor V Leiden clotting disorder, thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE))
Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia
The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, no subject with liver enzymes (ALT or AST) above 2 times the ULN, total bilirubin above 2 times the ULN, or serum creatinine above 1.5 ULN will be admitted to the study

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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 (may be eligible if allow a 6 week washout period after stopping antiandrogens);
History of prior treatment of cancer chemotherapy agent (other than hormone therapy) or radiopharmaceutical for prostate cancer.
Have taken ketoconazole within the previous 12 months prior to randomization into this study
Have taken diethylstilbestrol or other estrogen products, ketoconazole, or abiraterone within the previous 12 months prior to randomization into this study
Have taken body building or fertility supplements within 4 weeks of admission into the study
Have been previously diagnosed with cancer (other than prostate cancer, superficial bladder cancer, or non-melanoma skin cancer).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

GTx Investigative Site
Albuquerque, New Mexico, 87109
GTx Investigative Site
Bala-Cynwyd, Pennsylvania, 19004
GTx Investigational Site
Jeffersonville, Indiana, 47130
GTx Investigative Site
San Antonio, Texas, 78229
GTx Investigative Site
San Bernardino, California, 92404
GTx Investigative Site
Syracuse, New York, 13210
GTx Investigative Site
Virginia Beach, Virginia, 23462

Other trials in United States

About this study

Official title: Open Label Study of the Effect of GTx-758 on Serum PSA and Free Testosterone Levels in Men With Castration Resistant Prostate Cancer and Maintained on Androgen Deprivation Therapy

Conditions: Prostate Cancer
Being tested: GTx-758
Keywords: castrate resistant
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-758Drug
two GTx 758 tablets per day

Study groups in NCT01420861
Study group	Role	What they receive
1000 mg GTx-758 BID	Experimental	subjects will receive daily doses of 1000 mg GTx-758 Receives: Drug: GTx-758

What is being measured

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

Decline in Serum PSA
Measured: 30 days

Timeline

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

Sep 2011Dec 2012

First posted22 Aug 2011 (estimated)
Study startSep 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: Not applicable
Intervention model: Single group
Masking: Double blind
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01420861
Sponsor's protocol ID: G200707
Status last verified: Sep 2023
First submitted: 18 Aug 2011
Last updated: 6 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Study of the Effect of GTx-758 on Serum PSA and Free Testosterone Levels in Men With Castration Resistant Prostate Cancer and Maintained on Androgen Deprivation Therapy
ClinicalTrials.gov ID: NCT01420861
Acronym / sponsor ID: G200707
Conditions: Prostate Cancer
Keywords: castrate resistant
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: FDA Clinical Hold
Enrolment: 18 participants (actual)
Lead sponsor: GTxIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 22 Aug 2011 (estimated)
Results: Posted 6 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind
Number of arms: 1

Arm	Type	Receives
1000 mg GTx-758 BID	Experimental	Drug: GTx-758subjects will receive daily doses of 1000 mg GTx-758

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Be over 18 years of age
Be able to communicate effectively with the study personnel
Have histologically confirmed prostate cancer
ECOG performance status of 0 to 2
Have been treated with ADT(chemical or surgical) for at least 6 months

Key exclusion criteria (14 listed)

Known hypersensitivity or allergy to estrogen or estrogen like drugs;
Have symptomatic metastatic prostate cancer
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;
History of abnormal blood clotting, Factor V Leiden clotting disorder, thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE))
Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia

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-758two GTx 758 tablets per day	Drug	1000 mg GTx-758 BID

Primary outcome

Decline in Serum PSA
Time frame: 30 days

Results and safety

Results posted to the registry on 6 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1000 mg GTx-758 BID	18	0

Primary outcome: Decline in Serum PSA

Time frame: 30 days. Count of participants. Unit: Participants

Measure	1000 mg GTx-758 BID n = 9
2 consecutive 50% or more decline	3
1 50% or more decline without confirmation in next visit	1
No 50% or more decline observed	5

Population analysed: Treated Patients

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1000 mg GTx-758 BID	1 of 9 (11.1%)	7 of 9 (77.8%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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

7 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 in people with Prostate Cancer, run by GTx at 7 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 12 inclusion and 14 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 6 Oct 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?

Decline in Serum PSA (time frame: 30 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 NCT01420861.

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 6 Oct 2023.