Prostate CancerPhase 4EligardNCT01136226
Evaluate Recovery of Testosterone for Patients Using Eligard
A Phase 4 study testing Eligard (TM) in people with Prostate Cancer, run by Chesapeake Urology Research Associates.
Trial summary
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Eligard (TM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Jun 2009
- Phase
- Phase 4
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be outpatient, not hospitalized
- Male Patient between ages 50-80, inclusive
- Histologically/Cytologically graded adenocarcinoma of the prostate
- Must have T1, T2 or T3a adenocarcinoma of the prostate
- Must be a candidate for radiation therapy. Hormone refractory patients excluded
- WHO/ECOG score of 0,1 or 2
Who cannot join
- NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
- Used the following treatments for prostate Cancer
- immunotherapy chemotherapy External Beam Radiation brachytherapy hormonal therapy biological response modifiers
- Prior Prostate Surgery (excluding TUNA or TURP)
- Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
- Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer
Show all 16Show fewer
- Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect
- uncontrolled CHF within 6 months to baseline
- Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit
- Venous thrombosis with in 6 Months of Screening
- Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3 months of Baseline
- Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard.
- Drug or Alcohol Abuse 6 months prior to Baseline
- Other Serious Illness at the discretion of the Investigator
- Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline
- Hypersensitivity to GnRH, GnRH agonists
About this study
Official title: A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
Read the detailed description
This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).
- Conditions
- Prostate Cancer
- Being tested
- Eligard (TM)
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligard (TM)Drug
Eligard (TM) 22.5 mg administered at baseline and Month 3
| Study group | Role | What they receive |
|---|---|---|
| Eligard (TM) | Other | Eligard (TM) administered 22.5mg Receives: Drug: Eligard (TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Testosterone Recovery
To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer
Measured: 6 mos
Secondary outcomes (1)
Safety Assessments
Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startOct 2003
- Primary completionJun 2009
- Study completionJun 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chesapeake Urology Research Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136226
- Sponsor's protocol ID
- CURA-RT-001
- Acronym
- Eligard
- Status last verified
- Sep 2018
- First submitted
- 2 Jun 2010
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer
- ClinicalTrials.gov ID
- NCT01136226
- Acronym / sponsor ID
- Eligard / CURA-RT-001
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chesapeake Urology Research AssociatesUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Oct 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 16 Jul 2013
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 if testosterone will recover to 90% by year 1 after using Eligard.
Detailed description
This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligard (TM) | Other | Drug: Eligard (TM)Eligard (TM) administered 22.5mg |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be outpatient, not hospitalized
- Male Patient between ages 50-80, inclusive
- Histologically/Cytologically graded adenocarcinoma of the prostate
- Must have T1, T2 or T3a adenocarcinoma of the prostate
- Must be a candidate for radiation therapy. Hormone refractory patients excluded
Key exclusion criteria (16 listed)
- NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
- Used the following treatments for prostate Cancer
- immunotherapy chemotherapy External Beam Radiation brachytherapy hormonal therapy biological response modifiers
- Prior Prostate Surgery (excluding TUNA or TURP)
- Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
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 |
|---|---|---|
| Eligard (TM)Eligard (TM) 22.5 mg administered at baseline and Month 3 | Drug | Eligard (TM) |
Primary outcome
Serum Testosterone Recovery
Time frame: 6 mos
To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer
1 secondary outcome
Safety Assessments
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eligard (TM) in people with Prostate Cancer, run by Chesapeake Urology Research Associates.
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 6 inclusion and 16 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 16 Jul 2013). 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?
Serum Testosterone Recovery (time frame: 6 mos). 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 24 Oct 2018.