Prostate CancerPhase 3NCT00833248
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
A Phase 3 study testing Degarelix, Goserelin and Bicalutamide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 66 sites in 7 countries.
Trial summary
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. 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, Goserelin and Bicalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 66 sitesin 7 countries
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has given written informed consent before any trial-related activity is performed.
- Has a confirmed prostate cancer in which this type of treatment is needed.
Who cannot join
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Patients who are lymph node positive or have other metastatic disease
- Use of urethral catheter
- Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Show all 10Show fewer
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
- Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
- Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Trial locations and contacts
66 sites in 7 countries.
66 sites in 7 countries
United States19 sites
Urology Group of New Mexico
Albuquerque, New Mexico, 87109
Alaska Urological Association
Anchorage, Alaska, 99508
South Florida Medical Research
Aventura, Florida, 33180
Premier Medical Group of Hudson
Baldwinsville, New York, 12601
Alabama Research Center
Birmingham, Alabama, 35209
Summit Research Institute
Bloomington, Indiana, 47403
DCT -Celebration, LLC dba Discovery Clinical Trials
Celebration, Florida, 34747
Urology Center Research Institute
Englewood, New Jersey, 07631
Northeast Indiana Research
Fort Wayne, Indiana, 46825
Urology Centers of Alabama
Homewood, Alabama, 35209
Orange County Urology
Lagua Hills, California, 92653
Connecticut Clinical Research Center
Middlebury, Connecticut, 06762
Tri-Valley Urology Medical Group
Murrieta, California, 92563
Urology Associates
Nashville, Tennessee, 37209
University Urology Associates
New York, New York, 10016
Urology of Virginia
Norfolk, Virginia, 23502
Pinellas Urology Inc.
St. Petersburg, Florida, 33710
Arizona Urologic Specialists
Tuscon, Arizona, 85712
Palm Beach Urology Associates
Wellington, Florida, 33449
France19 sites
Hopital Jean Minjoz
Besançon, 25000
Institut Bergonié
Bordeaux, 33076
Centre Francois Baclesse
Caen, 14000
CHU Henri Mondor
Créteil, 94000
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69008
Hopital de la Timone
Marseille, 13385
CRLC Val d'Aurelle Oncology Radiotherapy
Montpellier, CX5 34298
Hôpital Tenon
Paris, 75000
Hôpital Saint Louis, Radiotherapy Departement
Paris, 75010
Clinique Francheville
Périgueux, 24000
CHU La Milétrie, Oncology Radiotherapy
Poitiers, 86000
Clinique Saint Brieuc
Saint-Brieuc, 22015
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
Saint-Herblain
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, CX 42271
Centre Paul Strauss
Strasbourg, 67085
Centre de radiologie Saint Louis
Toulon, 83100
Clinique du Parc
Toulouse, 31400
IGR
Villejuif, 94805
United Kingdom10 sites
Oncology Royal United Hospital Bath NHS Trust
Bath, BA1 3NG
Addenbrooke's Hospital, Oncology Centre
Cambridge, CB2 0QQ
St. James' University Hospital
Leeds, LS9 7TF
The Royal Marsden NHS, Foundation Trust
London, SW3 6JJ
Charing Cross Hospital
London, W6 8FR
Kent Oncology Centre Maidstone Hospital
Maidstone, Kent, ME16 9QQ
Northern Centre for Cancer Treatment, Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE
Mount Vernon Cancer Center
Northwood, Middlesex, HA6 2RN
Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre
Southhampton, SO16 6YD
Velindre Hospital, Cardiff University
Whitchurch, CF14 2TL
Netherlands6 sites
Albert Schweitzer Ziekenhuis, Ioc., Dordwijk
Dordrecht, 3318 AT
Groene Hart Ziekenhuis, urology
Gouda, 2803 HH
Franciscus Gasthuis, Dept. urology
Rotterdam, 3045 PM
Maastad Ziekenhuis, Ioc. Clara
Rotterdam, 3078HT
Vlietland Ziekenhuis, Dept. urology
Schiedam, 3118 JH
St. Elisabeth Ziekenhuis Tilburg
Tilburg, 5000 LC
Germany4 sites
Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie
Berlin, D-12203
Städtisches Klinikum Braunschweig
Braunschweig, D-38126
Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie
Dresden, D-01307
Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie
Ulm, D-89081
Greece4 sites
General University Hospital of Alexandroupolis
Alexandroupoli, 68100
General Hospital of Athens, "Sismanogleio", University of Athens, Marouse
Athens, 15126
University General Hospital of Loannina, Medical School
Loannina, 45110
University General Hospital of Patras
Pátrai, 26504
Spain4 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari Vall d´Hebron
Barcelona, 08035
Hospital Universitario La Paz
Madrid, 28046
Fundación IVO
Valencia, 46009
About this study
Official title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Goserelin, Bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called FE200486, Firmagon
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
GoserelinDrug
Also called Zoladex
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
BicalutamideDrug
Also called Casodex
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 240 mg/80 mg | Experimental | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. Receives: Drug: Degarelix |
| Goserelin (3.6 mg) + bicalutamide (50 mg) | Active comparator | On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. Receives: Drug: Goserelin; Drug: Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
TRUS is a method of measuring the size of the prostate.
Measured: After treatment of 12 weeks compared to Baseline
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
TRUS is a method of measuring the size of the prostate.
Measured: After treatment of 12 weeks compared to Baseline
Secondary outcomes (7)
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Testosterone Levels During the Study
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Oestradiol Levels During the Study
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Measured: Baseline to 12 weeks of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Measured: Baseline to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionSep 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833248
- Sponsor's protocol ID
- FE200486 CS30
- Other IDs
- 2008-005232-33, 2008
- Status last verified
- Sep 2012
- First submitted
- 30 Jan 2009
- Last updated
- 4 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
PubMed 34350976Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.
PubMed 23257248
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
- ClinicalTrials.gov ID
- NCT00833248
- Acronym / sponsor ID
- FE200486 CS30
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 27 Sep 2012
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 phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix 240 mg/80 mg | Experimental | Drug: DegarelixThe degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. |
| Goserelin (3.6 mg) + bicalutamide (50 mg) | Active comparator | Drug: Goserelin, Drug: BicalutamideOn Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has given written informed consent before any trial-related activity is performed.
- Has a confirmed prostate cancer in which this type of treatment is needed.
Key exclusion criteria (10 listed)
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Patients who are lymph node positive or have other metastatic disease
- Use of urethral catheter
- Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
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 |
|---|---|---|
| DegarelixAlso: FE200486, FirmagonThe degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | Drug | Degarelix 240 mg/80 mg |
| GoserelinAlso: ZoladexGoserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively. | Drug | Goserelin (3.6 mg) + bicalutamide (50 mg) |
| BicalutamideAlso: CasodexOn Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin. | Drug | Goserelin (3.6 mg) + bicalutamide (50 mg) |
Primary outcome
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Time frame: After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
Time frame: After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
7 secondary outcomes
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Testosterone Levels During the Study
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Serum Oestradiol Levels During the Study
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame: Baseline to 12 weeks of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame: Baseline to 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34350976Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
- Derived from this study: PubMed 23257248Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
66 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix, Goserelin and Bicalutamide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 66 sites in 7 countries.
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 2 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: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, France, United Kingdom, Netherlands, Germany and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Sep 2012). 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?
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) (time frame: After treatment of 12 weeks compared to Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833248, which also lists 2 linked publications.
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 4 Oct 2012.