Trial · NCT00833248
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT00833248, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2012-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer. Trials, record NCT00833248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00833248
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
- NCT number
- NCT00833248
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 246 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Prostate Cancer
- Interventions
- Degarelix, Goserelin, Bicalutamide
- First posted
- 2009-02-02
- Last updated
- 2012-10-04
- Other registries' IDs
- eudract:2008-005232-33
- Results first posted
- 2012-09-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | After treatment of 12 weeks compared to Baseline | TRUS is a method of measuring the size of the prostate. |
| Primary | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | After treatment of 12 weeks compared to Baseline | TRUS is a method of measuring the size of the prostate. |
| Secondary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | After treatment of 4, 8, and 12 weeks compared to Baseline | 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. |
| Secondary | Change From Baseline in Serum Testosterone Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline | |
| Secondary | Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline | |
| Secondary | Change From Baseline in Serum Oestradiol Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline | |
| Secondary | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | After treatment of 4, 8, and 12 weeks compared to Baseline | 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'). |
| Secondary | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Baseline to 12 weeks of treatment | 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. |
| Secondary | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | Baseline to 12 weeks of treatment | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | After treatment of 12 weeks compared to Baseline | FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis. | milliliter | MEAN |
| PRIMARY | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | After treatment of 12 weeks compared to Baseline | FAS, OC. | milliliter | MEAN |
| SECONDARY | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | After treatment of 4, 8, and 12 weeks compared to Baseline | FAS, OC. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Serum Testosterone Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline | FAS, OC. | nanograms per milliliter | MEDIAN |
| SECONDARY | Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline | FAS, OC. | nanograms per milliliter | MEDIAN |
| SECONDARY | Change From Baseline in Serum Oestradiol Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline | FAS, OC. | nanogram per deciliter | MEDIAN |
| SECONDARY | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | After treatment of 4, 8, and 12 weeks compared to Baseline | FAS, OC. | scores on a scale | MEAN |
| SECONDARY | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Baseline to 12 weeks of treatment | Safety analysis set. | participants | NUMBER |
| SECONDARY | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | Baseline to 12 weeks of treatment | Safety analysis set. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | Degarelix 240 mg/80 mg | -36.0 | Standard Deviation 14.5 | milliliter | |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | Goserelin (3.6 mg) + Bicalutamide (50 mg) | -35.3 | Standard Deviation 16.7 | milliliter | |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | Degarelix 240 mg/80 mg | -36.2 | Standard Deviation 14.5 | milliliter | |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | Goserelin (3.6 mg) + Bicalutamide (50 mg) | -35.4 | Standard Deviation 16.9 | milliliter | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Degarelix 240 mg/80 mg | Week 4 | -0.21 | Standard Deviation 5.05 | scores on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Week 4 | 0.36 | Standard Deviation 4.83 | scores on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Degarelix 240 mg/80 mg | Week 8 | -1.53 | Standard Deviation 5.43 | scores on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Week 8 | 0.02 | Standard Deviation 5.41 | scores on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Degarelix 240 mg/80 mg | Week 12 | -1.71 | Standard Deviation 5.54 | scores on a scale |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Week 12 | 0.11 | Standard Deviation 5.13 | scores on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Degarelix 240 mg/80 mg | 181 | |
| Overall Study | STARTED | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 65 | |
| Overall Study | Full Analysis Set (FAS) | Degarelix 240 mg/80 mg | 180 | |
| Overall Study | Full Analysis Set (FAS) | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 64 | |
| Overall Study | Per Protocol (PP) Analysis Set | Degarelix 240 mg/80 mg | 164 | |
| Overall Study | Per Protocol (PP) Analysis Set | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 57 | |
| Overall Study | Safety Analysis Set | Degarelix 240 mg/80 mg | 181 | |
| Overall Study | Safety Analysis Set | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 64 | |
| Overall Study | COMPLETED | Degarelix 240 mg/80 mg | 177 | |
| Overall Study | COMPLETED | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | Degarelix 240 mg/80 mg | 60 | 181 | 93 |
| other | Injection site pain | General disorders | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 1 | 64 | 1 |
| other | Injection site erythema | General disorders | Degarelix 240 mg/80 mg | 45 | 181 | 73 |
| other | Injection site erythema | General disorders | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 0 | 64 | 0 |
| other | Asthenia | General disorders | Degarelix 240 mg/80 mg | 13 | 181 | 15 |
| other | Asthenia | General disorders | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 6 | 64 | 6 |
| other | Injection site pruritus | General disorders | Degarelix 240 mg/80 mg | 13 | 181 | 19 |
| other | Injection site pruritus | General disorders | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 0 | 64 | 0 |
| other | Fatigue | General disorders | Degarelix 240 mg/80 mg | 11 | 181 | 13 |
| other | Fatigue | General disorders | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 6 | 64 | 6 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Degarelix 240 mg/80 mg | ||
| Total, all-cause mortality | Goserelin (3.6 mg) + Bicalutamide (50 mg) | ||
| Total, other adverse events | Degarelix 240 mg/80 mg | 158 | 181 |
| Total, other adverse events | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 53 | 64 |
| Total, serious adverse events | Degarelix 240 mg/80 mg | 7 | 181 |
| Total, serious adverse events | Goserelin (3.6 mg) + Bicalutamide (50 mg) | 0 | 64 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Degarelix 240 mg/80 mg vs Goserelin (3.6 mg) + Bicalutamide (50 mg): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00833248
GET https://conductscience.org/api/trials/v1/NCT00833248/results?page=2