Prostatic Intraepithelial NeoplasiaPhase 2NCT00028353
A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
A Phase 2 study testing GTX-006 (Acapodene) in people with Prostatic Intraepithelial Neoplasia, run by GTx at 25 sites in United States.
Trial summary
If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Prostatic Intraepithelial Neoplasia
- What is being tested?
- GTX-006 (Acapodene)
- How many people
- 500 participants
- Where
- 25 sitesUnited States
- Study dates
- Apr 2001to Jul 2003
- Phase
- Phase 2
- 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 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
- Must have confirmed high grade PIN on prostate biopsy within past 6 months.
- Must have a serum PSA <12 ng/ml.
- Can not have prostate cancer.
- Have significant ocular opacities.
- Can not take finasteride or other testosterone like supplement.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Sandy Springs Urology, P.C.
Atlanta, Georgia, 30328
South Florida Medical Research
Aventura, Florida, 33180
Urologic Surgery, P.C
Bala-Cynwyd, Pennsylvania, 19004
Medical & Clinical Research Associates
Bay Shore, New York, 11706
Tri-State Urologic Services
Cincinnati, Ohio, 45212
North Idaho Urology
Couer D'Alene, Idaho, 83814
Private Practice
Huntsville, Alabama, 35801
Wishard Memorial Hospital
Indianapolis, Indiana, 46202
Urology Associates of Lancaster
Lancaster, Pennsylvania, 17604
Private Practice
Las Vegas, Nevada, 89109
UroSearch
Leesburg, Florida, 34748
Arkansas Urology Associates
Little Rock, Arkansas, 72211
Clinical Research of Westchester
New Rochelle, New York, 10801
Columbia University
New York, New York, 10032
Newton Wellesley Urology
Newton, Massachusetts, 02162
The Urology Center of Florida Inc.
Ocala, Florida, 34474
UroSearch
Ocala, Florida, 34474
Dr. Byron Hodge
Orlando, Florida, 32806
Mid Atlantic Clinical Research
Rockville, Maryland, 20850
Urology San Antonio Research
San Antonio, Texas, 78229
Seattle Urological Associates
Seattle, Washington, 98104
Private Practice
Staten Island, New York, 10305
Madigan Army Medical Center
Tacoma, Washington, 98431
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497
Salem Research Group, Inc.
Winston-Salem, North Carolina, 27103
About this study
If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.
Read the detailed description
High grade PIN is the development of precancerous, abnormal tissue of the prostate gland that puts men at high risk of developing prostate cancer. This study will take one year of participation with clinic visits every three months. There will be two prostate biopsies during the study, at six and twelve months. If qualified to participate, you will be randomly assigned to one of four treatment groups. Three out of four groups are varying doses of the study medication and the other is the placebo group (like a sugar pill).
- Conditions
- Prostatic Intraepithelial Neoplasia
- Being tested
- GTX-006 (Acapodene)
- Keywords
- PIN, High Grade Prostate Intraepithelial Neoplasia (PIN)
- Medical subject headings
- Prostatic Intraepithelial Neoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX-006 (Acapodene)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2001 (estimated)
- Study startApr 2001
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Intraepithelial NeoplasiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028353
- Sponsor's protocol ID
- 211
- Status last verified
- Nov 2013
- First submitted
- 22 Dec 2001
- Last updated
- 15 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
- ClinicalTrials.gov ID
- NCT00028353
- Acronym / sponsor ID
- 211
- Conditions
- Prostatic Intraepithelial Neoplasia
- Keywords
- PIN, High Grade Prostate Intraepithelial Neoplasia (PIN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Jul 2003
- First posted
- 24 Dec 2001 (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.
If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.
Detailed description
High grade PIN is the development of precancerous, abnormal tissue of the prostate gland that puts men at high risk of developing prostate cancer. This study will take one year of participation with clinic visits every three months. There will be two prostate biopsies during the study, at six and twelve months. If qualified to participate, you will be randomly assigned to one of four treatment groups. Three out of four groups are varying doses of the study medication and the other is the placebo group (like a sugar pill).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-006 (Acapodene) | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Nov 2013.
- Related InfoLink provided by the sponsor.
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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.
25 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-006 (Acapodene) in people with Prostatic Intraepithelial Neoplasia, run by GTx at 25 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?
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 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
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.
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 15 Nov 2013.