Phase 3
Completed N=403
A Study of Degarelix in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00928434 ↗Enrolled (actual)
403
Serious AEs
12.4%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL — 100; 98.4 Percentage of patients
◆ Published Evidence
Established
25citations · ~5 / year
Degarelix for treating advanced hormone-sensitive prostate cancer.
Summary
The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.
Linked Publications
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Degarelix for treating advanced hormone-sensitive prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL |
100; 98.4 | — |
| SECONDARY Absolute Change From Baseline in Serum PSA Levels |
NA; -0.91; NA; -6.39; -14.3; -6.38 | — |
| SECONDARY Percent Change From Baseline in Serum PSA Levels |
NA; -39.6; NA; -80.8; -84.5; -62.8 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being |
-1.47; -1.63; -1.41; -1.46; -1.41; -1.48 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being |
0.69; 1.31; 0.76; 0.88; 0.67; 0.57 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being |
-0.18; -0.06; -0.36; -0.30; 0.00; -0.30 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being |
-0.96; -0.88; -0.29; -0.42; -1.41; -0.78 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns |
-1.14; -0.92; -0.51; -0.60; -0.89; -1.34 | — |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score |
-1.86; -1.89; -1.23; -1.37; -2.03; -2.64 | — |
| SECONDARY Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive |
-1.57; -1.57; -1.27; -1.33; -1.71; -1.39 | — |
| SECONDARY Change From Baseline in Sexual Function as Assessed by the SFI: Erection |
-1.32; -0.91; -1.21; -1.14; -1.43; -1.06 | — |
| SECONDARY Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation |
-1.04; -0.90; -0.87; -0.88; -1.23; -0.80 | — |
| SECONDARY Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment |
-0.26; -0.58; -0.36; -0.40; -0.90; -0.88 | — |
| SECONDARY Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life |
-0.32; -0.18; -0.27; -0.25; -0.28; -0.37 | — |
| SECONDARY Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score |
-4.07; -3.93; -3.69; -3.74; -5.20; -4.28 | — |
| SECONDARY Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL |
100; 97.6; 98.7 | — |
| SECONDARY Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group |
112.0 | — |
| SECONDARY Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level |
168 | — |
| SECONDARY Absolute Change From Baseline in Serum Testosterone Levels |
NA; -2.97; NA; -3.64; -3.77; -3.7 | — |
| SECONDARY Percent Change From Baseline in Serum Testosterone Levels |
NA; -95.8; NA; -96.4; -97.4; -95.5 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older.
- Raising PSA after prior treatment failure of localized prostate cancer.
- Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
- Has a screening testosterone within normal range (≥1.5 ng/mL).
- Has Eastern Cooperative Oncology Group score of ≤2.
- Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
- Life expectancy of at least 15 months.
Exclusion Criteria
- Taken hormone therapy in the last 6 months prior to entering this study.
- Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
- Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Has hypersensitivity towards any component of the study drug.
- Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.
- Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
- Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
- Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
- Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
- Has previously participated in any Degarelix trial.
- Is part of an ongoing trial.
Data sourced from ClinicalTrials.gov (NCT00928434) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.