Prostate CancerNCT01344564
Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide
A study testing Degarelix acetate, Leuprolide acetate in people with Prostate Cancer, run by Urology of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. 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?
- Degarelix acetate, Leuprolide acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- 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
- 18 years or older
- Histologically confirmed adenocarcinoma of the prostate
- Androgen deprivation therapy is indicated
Who cannot join
- Baseline screening serum testosterone <150ng/dL
- Eastern Cooperative Oncology Group (ECOG) score > 2
- Diagnosed spinal or brain metastases
- Hormonal manipulation within previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix acetate, Leuprolide acetate
- Keywords
- Prostate cancer, Hormone therapy, Testosterone measures
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix acetate, Leuprolide acetateDrug
Also called Firmagon, Eligard
Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once
| Study group | Role | What they receive |
|---|---|---|
| ADT | Other | All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot. Receives: Drug: Degarelix acetate, Leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone measurement
Measured: 11 times over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urology of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Robert Given, MD, Principal investigator, Urology of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344564
- Sponsor's protocol ID
- UVA002
- Status last verified
- Mar 2013
- First submitted
- 27 Apr 2011
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
- ClinicalTrials.gov ID
- NCT01344564
- Acronym / sponsor ID
- UVA002
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Hormone therapy, Testosterone measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Urology of VirginiaUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Apr 2011 (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.
The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADT | Other | Drug: Degarelix acetate, Leuprolide acetateAll subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Histologically confirmed adenocarcinoma of the prostate
- Androgen deprivation therapy is indicated
Key exclusion criteria (4 listed)
- Baseline screening serum testosterone <150ng/dL
- Eastern Cooperative Oncology Group (ECOG) score > 2
- Diagnosed spinal or brain metastases
- Hormonal manipulation within previous 6 months
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 |
|---|---|---|
| Degarelix acetate, Leuprolide acetateAlso: Firmagon, EligardDegarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once | Drug | ADT |
Primary outcome
Testosterone measurement
Time frame: 11 times over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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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.
Robert Given, MD principal investigator
Urology of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Degarelix acetate, Leuprolide acetate in people with Prostate Cancer, run by Urology of Virginia at 1 site 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 3 inclusion and 4 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Testosterone measurement (time frame: 11 times over 6 months). 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 18 Mar 2013.