A Study of Degarelix in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Leuprolide

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.