Prostate cancer
Conditions
Interventions
Cohort 1 (subcutaneous injection of goserelin implant):None
Cohort 2 (subcutaneous goserelin microspheres):None
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The patient is able to give informed consent, complete all study evaluations, and have complete medical records; 2. Confirmed prostate cancer through serum prostate-specific antigen (PSA), imaging examination and pathological examination of prostate biopsy; 3. Documented clinical stages of T3 and T4 (N0 or N1); 4. ECOG score is 0-2 points; 5. No prior anti-androgen-based endocrine therapy and any form of cytotoxic drug therapy; 6. The intervention was used as a monotherapy or in combination with androgen-blocking drugs (CABs); 7. Estimated survival > 26 weeks.
Exclusion criteria
Exclusion criteria: 1. Patients with other tumors; 2. Hypersensitivity to any component of LHRH, goserelin and their analogues; 3. Prior or concurrent hormonal therapy, including surgical castration, androgen blockers, estrogen therapy, or other LHRH agonists; 4. Have had pituitary resection, adrenalectomy, orchiectomy or have pituitary lesions; 5. Plan to receive radiotherapy as curative therapy (except for adjuvant radiotherapy after RP combined with goserelin) or neoadjuvant hormonal therapy after RP; 6. Occurrence of baseline abnormal results, or any medical or psychiatric illness or laboratory abnormal results, which, in the judgment of the investigator, may endanger patient safety or interfere with the study evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in mean serum testosterone and PSA from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average serum testosterone and PSA levels;Number and proportion of patients achieving chemical castration criteria (serum testosterone <50 ng/dL);Number and proportion of patients achieving chemical castration (serum testosterone <20 ng/dL);Incidence of adverse drug reactions;The incidence of adverse events;The incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactZhang Hongliang
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed