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Clinical study of rezvilutamide inhibiting the flare effect of GnRH agonists in the treatment of newly diagnosed metastatic prostate cancer

Clinical study of rezvilutamide inhibiting the flare effect of GnRH agonists in the treatment of newly diagnosed metastatic prostate cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076106
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Prostate cancer

Interventions

Control group:Take rezvilutamide orally 1 day in advance before GnRH agonist (Goserelin).
Experimental group:Interval of 1 hour between rezvilutamide and GnRH agonist (Goserelin).

Sponsors

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years, and within 1 month of initial diagnosis of prostate adenocarcinoma by pathology. 2. Prior to initiation of treatment, a bone scan, chest and abdominal CT, and pelvic MRI were performed, which were sufficient for TNM staging, with at least one distant metastasis (extra-pelvic lymph node metastasis, bone metastasis, or visceral metastasis). 3. PSA > 2 ng/ml at initiation of therapy, and serum testosterone level greater than 150 ng/dl.

Exclusion criteria

Exclusion criteria: 1. Combinations of severe cardio-cerebral and pulmonary systemic diseases that interfere with the implementation of the treatment program. 2. Prostate adenocarcinoma non-major component. 3. Clinical situations in which indwelling urinary catheters, punctures, and acute infections significantly affect PSA levels within 1 week. 4. Patients who cannot be followed up regularly during treatment for reasons such as poor adherence.

Design outcomes

Primary

MeasureTime frame
Prostate-specific antigen;Luteinizing hormone;Testosterone;Imaging changes;

Secondary

MeasureTime frame
Changes in clinical symptoms;

Countries

China

Contacts

Public ContactChunguang Yang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

cgyang-hust@hotmail.com+86 138 7108 4204

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026