efficacy and tolerability of 3- and 6- month leuprorelin acetate depot formulations (Eligard) for patients with prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005611

Enrollment

Registered

2020-11-23

Start date

2020-02-10

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : ? Test drug: Eligard® 45.0mg is injected subcutaneously once every 6 months. ? Reference drug: Eligard® 22.5mg is injected subcutaneously once every 3 months.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in blood PSA and Testosterone concentration compared to baseline	—

Secondary

Measure	Time frame
Whether the disease has progressed in the imaging examination (abdominal pelvis CT, MRI, bone scan) compared to baseline	—

Countries

Korea, Republic of

Contacts

Public ContactKim Tae Hyunh

Chung-Ang University

kthlmk@nate.com+82-2-6299-1818

Outcome results