Prostate CancerPhase 4NCT02749825
Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer
A Phase 4 study testing Trelstar, Lupron and Zoladex in people with Prostate Cancer, run by Pharmatech at 11 sites in United States.
Trial summary
This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA. 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?
- Trelstar, Lupron and Zoladex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2002to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Advanced Prostate Cancer
- Currently taking Lupron or Zoladex
- Stable PSA
- Baseline testosterone below castration level
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group performance status of 0-2
- Signed, approved informed consent.
Who cannot join
- Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
- Ongoing therapy with hyperprolactinemic agents
- Antiandrogen therapy within 28 days prior to study start
- Prior Orchiectomy, hypophysectomy or adrenalectomy
- Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
- Use of any investigational agent 3 months prior to enrollment
Show all 10Show fewer
- Use of systemic corticosteroids within 28 days or during study
- Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
- Severe kidney or liver failure, based on adequate lab values
- Other medical conditions which would be likely to interfere with compliance or completion of study requirements
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Albemarle Urology Clinic, PA
Albemarle, North Carolina, 28001
Raj P. Chopra MD, PC
Bloomsburg, Pennsylvania, 17815
Brooklyn Heights Urology Associates
Brooklyn, New York, 11201
Jazrawi-Atallah, P.C.
Brooklyn, New York, 11201
California Oncology of the Central Valley
Fresno, California, 93710
Heritage Physician Group - Urology Department
Hot Springs, Arkansas, 71913
Scott A Slavis, MD, PC
Las Vegas, Nevada, 89109
UroSearch
Ocala, Florida, 34470
Shaukat M Qureshi, MD
Pennsville, New Jersey, 08070
San Bernardino Urological Associates Medical Group
San Bernardino, California, 92404
Arizona Urologic Specialists
Tucson, Arizona, 85712-5803
About this study
Official title: A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer
This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.
Read the detailed description
Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months. At the end of that period, testosterone and prostate serum antigen (PSA) levels will be drawn and compared to their previous levels to determine if Trelstar is as effective as the previous treatment.
- Conditions
- Prostate Cancer
- Being tested
- Trelstar, Lupron, Zoladex
- Keywords
- Prostate, Cancer, Trelstar
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrelstarDrug
Also called Triptorelin pamoate
As labeled
LupronDrug
Also called luprolide acetate for depot suspension
As labeled
ZoladexDrug
Also called goserelin acetate
As labeled
| Study group | Role | What they receive |
|---|---|---|
| Trelstar | Experimental | Per prescribing information Receives: Drug: Trelstar |
| Lupron | Active comparator | Per prescribing information Receives: Drug: Lupron |
| Zoladex | Active comparator | Per prescribing information Receives: Drug: Zoladex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of serum testosterone at or below castration level (50ng/dL)
Primary efficacy
Measured: 12 weeks
Secondary outcomes (3)
Serum testosterone level at end of study
Secondary efficacy
Measured: Week 12
Change in serum testosterone from baseline to end of study
Secondary efficacy
Measured: Baseline and week 12
Incidence and severity of adverse events
Treatment tolerability
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startSep 2002
- Primary completionMay 2006
- Study completionJul 2006
Why it stopped: Withdrawal of funding support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmatech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Manyak, Michael, M.D., Watson Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael Michael Manyak, MD, Principal investigator, Georege Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749825
- Sponsor's protocol ID
- PUI-02809
- Status last verified
- May 2012
- First submitted
- 8 May 2012
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT02749825
- Acronym / sponsor ID
- PUI-02809
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Trelstar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawal of funding support
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PharmatechIndustry (pharma, biotech, devices)
- Collaborators
- Manyak, Michael, M.D., Watson Pharmaceuticals
- Study start
- Sep 2002
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.
Detailed description
Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months. At the end of that period, testosterone and prostate serum antigen (PSA) levels will be drawn and compared to their previous levels to determine if Trelstar is as effective as the previous treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trelstar | Experimental | Drug: TrelstarPer prescribing information |
| Lupron | Active comparator | Drug: LupronPer prescribing information |
| Zoladex | Active comparator | Drug: ZoladexPer prescribing information |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced Prostate Cancer
- Currently taking Lupron or Zoladex
- Stable PSA
- Baseline testosterone below castration level
- Life expectancy > 6 months
Key exclusion criteria (10 listed)
- Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
- Ongoing therapy with hyperprolactinemic agents
- Antiandrogen therapy within 28 days prior to study start
- Prior Orchiectomy, hypophysectomy or adrenalectomy
- Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
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 |
|---|---|---|
| TrelstarAlso: Triptorelin pamoateAs labeled | Drug | Trelstar |
| LupronAlso: luprolide acetate for depot suspensionAs labeled | Drug | Lupron |
| ZoladexAlso: goserelin acetateAs labeled | Drug | Zoladex |
Primary outcome
Maintenance of serum testosterone at or below castration level (50ng/dL)
Time frame: 12 weeks
Primary efficacy
3 secondary outcomes
Serum testosterone level at end of study
Time frame: Week 12
Change in serum testosterone from baseline to end of study
Time frame: Baseline and week 12
Incidence and severity of adverse events
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Withdrawal of funding support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Pharmatech - The Research Link websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael Michael Manyak, MD principal investigator
Georege Washington University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trelstar, Lupron and Zoladex in people with Prostate Cancer, run by Pharmatech at 11 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 7 inclusion and 10 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Withdrawal of funding support). Results are not available in the source record.
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?
Maintenance of serum testosterone at or below castration level (50ng/dL) (time frame: 12 weeks). 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 25 Apr 2016.