efficacy and tolerability of 3- and 6- month leuprorelin acetate depot formulations (Eligard) for patients with prostate cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0005611
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
We demonstrated the non-inferiority and confirmed the safety of Eligard® 6-month regimen following a 3-month regimen compared to Eligard® 3-month regimen following a 6-month regimen in prostate cancer patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 26
1) Men over 19 years of age
2) ECOG performance status is within 0-2 and the purpose of the study
Who understand and agree in writing to participate in the research
3) Patients confirmed as adenocarcinoma as a result of prostate biopsy
4) In the case of patients who cannot or are at high risk for prostate biopsy,
If it is possible to diagnose lip adenocarcinoma (more than 100 ng/ml of PSA, or/and in imaging
Clear prostate cancer lesions or/and obvious metastatic lesions on imaging tests, etc.)
5) Among prostate cancer patients, they were diagnosed with stage metastatic (stage D1, D2) and were treated with hormones.
6) Primary ADT for high-risk local or locally advanced prostate cancer (stage A, B)
7) Adjuvant therapy after radiotherapy or radical prostatectomy in prostate cancer patients.Patients planning hormone therapy
1) Severe heart disease (unstable angina, congestive herat failure), severe renal impairment Ruler (GFR <30 ml/min/1.73m2
), patients with severe liver failure (Child-Pugh class B, C)
2) Patients with hypersensitivity or allergic symptoms to Leuprorelin acetate
3) Severe cognitive dysfunction and psychiatric problems are inappropriate for surveys and verbal communication. character
4) Those who are inappropriate to participate in clinical trials under the judgment of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in blood PSA and Testosterone concentration compared to baseline
- Secondary Outcome Measures
Name Time Method Whether the disease has progressed in the imaging examination (abdominal pelvis CT, MRI, bone scan) compared to baseline