Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer

Short name GTx758

Overview

Status
Terminated
Phase
Phase 2
Enrollment
159 participants (actual)
Sponsor
GTx · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2011
Primary completion
Dec 2012
Completion
Dec 2012
First posted
30 Mar 2011 (estimated)
Last update posted
22 Jun 2023
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 2

    GTx758

    NCT01326312

    Jun 2011 to Dec 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GTx-758 1000mgDrug
  • Lupron DepotDrug
  • GTx-758 2000mgDrug

Arms3

  • Experimental

    GTx- 758 1000mg

    GTx-758/Experimental/ nonsteroidal selective ER alpha agonist

  • Experimental

    GTx-758 2000mg

    GTx-758/Experimental/ nonsteroidal selective ER alpha agonist

  • Active comparator

    Lupron Depot

    Luteinizing Hormone Releasing Hormone Agonist

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Who Are Castrate by Day 60

    Time frame · 60 days

Secondary outcomes(2)
  1. 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

  2. Time to Castration in Participants With Prostate Cancer

    Time frame · 60 days

    Registry description

    Median time to castration was summarized using the Kaplan-Meier method.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 60 days

Number of Participants Who Are Castrate by Day 60

GroupValue (participants)
GTx- 758 1000mg19
GTx-758 2000mg34
Lupron Depot43
Secondary and other outcome results(2)
Secondary outcomeCount of participants· 12 months

Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.

GroupValue (Participants)
GTx- 758 1000mg0
GTx-758 2000mg3
Lupron Depot9
Secondary outcomeMedian· 60 days

Time to Castration in Participants With Prostate Cancer

GroupValue (days)
GTx-758 1000mg29
GTx-758 2000mg21
Lupron Depot21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GTx- 758 1000mgGTx-758/Experimental/ nonsteroidal selective ER alpha agonist GTx-758 2000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension1 / 5311 / 5346 / 53
GTx-758 2000mgGTx-758/Experimental/ nonsteroidal selective ER alpha agonist GTx-758 1000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension0 / 556 / 5549 / 55
Lupron DepotLuteinizing Hormone Releasing Hormone Agonist Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension1 / 514 / 5148 / 51

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 45 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. be between age 45 and 80 years of age 2. be able to communicate effectively with study personnel 3. ECOG is \< or = 2 4. screening serum total testosterone\> or = 150ng/dL 5. have prostate cancer, confirmed by pathology report 6. have not been treated with androgen deprivation therapy(chemical or surgical 7. have a clinical indication for the initiation of androgen deprivation therapy 8. give written informed consent prior to any study specific procedures 9. subject must agree to use acceptable methods of contraception Exclusion Criteria: 1. known hypersensitivity or allergy to estrogen or estrogen like drugs 2. 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 3. history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease 4. have ALT or AST above 2 times the upper normal limit 5. have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline 6. patients cannot have brain or spinal cord metastases 7. patients cannot have or be at risk for spinal cord compression from bone metastases 8. received an investigational drug within a period of 90 days prior to enrollment in the study 9. received the study medication previously 10. currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization 11. currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization) 12. have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization 13. have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements) 14. 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 15. 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.