Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
One month degarelix/comparator treatment for prostate cancer in Chinese population
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental | Degarelix 240/80 mg |
|
| Goserelin | Active Comparator | Goserelin 3.6 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug |
| ||
| Goserelin |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) | Day 28 to Day 364 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with testosterone levels ≤0.5 ng/mL | at Day 3 | |
| Percentage change in prostate-specific antigen (PSA) | from baseline to Day 28 | |
| Changes in testosterone and PSA levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute & Hospital. Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34350976 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 0 to 364 |
| Significant changes in laboratory values | Day 0 to Day 364 |
| Significant changes in vital signs | Day 0 to Day 364 |
| Significant changes in body weight | Day 0 to Day 364 |
| Frequency and severity of adverse events | Day 0 to Day 364 |
| Cumulative probability of no PSA failure | PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir | Day 0 to Day 364 |
| Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army |
| Chongqing |
| Chongqing Municipality |
| China |
| 1st Afilliated Hospital of Guangzhou Medical College | Guangzhou | Guangdong | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| 2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine | Xi’an | Shanxi | China |
| 1st Hospital Affiliated to Zhejiang University Medical School | Hangzhou | Zhejiang | China |
| Beijing Hospital of Ministry of Health | Beijing | China |
| Peking Union Hospital | Beijing | China |
| Peking University 3rd Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| 1st Hospital of Jilin University | Changchun | China |
| Hunan Cancer Hospital | Changsha | China |
| Hunan Province People's Hospital | Changsha | China |
| People's Hospital of Sichuan | Chengdu | China |
| 2nd Hospital Affiliated to Zhejiang University Medical School | Hangzhou | China |
| 1st Hospital of Lanzhou University | Lanzhou | China |
| 1st Affiliated Hospital of Nanchang University | Nanchang | China |
| 1st Affiliated Hospital of Nanjing Medical University | Nanjing | China |
| Drum Tower Hospital Affiliated to Nanjing University Medical School | Nanjing | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Huashan Hospital of Fudan University | Shanghai | China |
| Shanghai 5th People's Hospital affilicated to Fudan University | Shanghai | China |
| Shanghai Changhai Hospital | Shanghai | China |
| 1st Hospital Affiliated to China Medical University | Shenyang | China |
| 2nd Hospital Affiliated to Suzhou University | Suzhou | China |
| 2nd Hospital of Tianjin Medical University | Tianjin | China |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| Zhongnan Hospital of Wuhan University | Wuhan | China |
| 1st People's Hospital of Wuxi | Wuxi | China |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided