Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

• ClinicalTrials.gov Identifier: NCT01071915
• Recruitment Status: Completed
• First Posted: February 19, 2010
• Results First Posted: February 12, 2013
• Last Update Posted: February 12, 2013
• Sponsor: Ferring Pharmaceuticals
• Collaborator: Ferring Pharmaceuticals Korea, Ltd.
• Information provided by (Responsible Party): Ferring Pharmaceuticals

Study Description

Brief Summary:

This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Degarelix 240/80 mg	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 157 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy
• Study Start Date: March 2010
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm

Intervention/treatment

Experimental: Degarelix 240/80 mg; 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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Drug: Degarelix 240/80 mg; 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 subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.; Other Names: FE200486; FIRMAGON

Outcome Measures

Primary Outcome Measures :

1. Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 [ Time Frame: Day 28 to Day 196 ]

Secondary Outcome Measures :

1. Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 [ Time Frame: At day 3 ]
2. Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 [ Time Frame: To Day 28 ]
3. Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 [ Time Frame: Day 56 to Day 196 ]
4. Cumulative Probability of no PSA Failure From Day 28 to Day 196 [ Time Frame: To Day 196 ]
   PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
5. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: To Day 196 ]
   The figures present the number of participants who had markedly abnormal 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.
6. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: To Day 196 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Has given written informed consent before any trial-related activity is performed.
• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
• Is a male patient aged 18 years or older
• Has a screening serum testosterone level >1.5 ng/mL
• Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
• Has a screening PSA value of ≥2 ng/mL
• Has a life expectancy of at least 12 months

Exclusion Criteria:

• Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
• Is currently treated with a 5-α-reductase inhibitor
• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
• Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
• Has hypersensitivity towards any component of the investigational medicinal product
• A marked baseline prolongation of QT/QTcF interval
• A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
• Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
• Has a known or suspect hepatic, symptomatic biliary disease
• Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
• Has other clinically significant laboratory abnormalities
• Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
• Has a mental incapacity or language barriers precluding adequate understanding or co- operation
• Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
• Has previously participated in any degarelix trial

Contacts and Locations

Locations

Korea, Republic of

Hallym University Sacred Heart Hospital

Pyungchon, Gyunggi-do, Korea, Republic of

Pusan National University Yangsan Hospital

Mulgeum-eup, Gyungnam, Korea, Republic of

Kyoungbuk National University Hospital

Daegu, Korea, Republic of

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of

Korea University Hospital

Seoul, Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Seoul St. Mary's Hospital

Seoul, Korea, Republic of

Yonsei University Health System (Sevrance Hospital)

Seoul, Korea, Republic of

Yonsei University Health System Gangnam Sevrance

Seoul, Korea, Republic of

Sponsors and Collaborators

Ferring Pharmaceuticals

Ferring Pharmaceuticals Korea, Ltd.

Investigators

• Study Director: Clinical Development Support; Ferring Pharmaceuticals

More Information

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01071915
• Other Study ID Numbers: FE200486 CS42
• First Posted: February 19, 2010
• Results First Posted: February 12, 2013
• Last Update Posted: February 12, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases