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A real-world observational study on the trends of PSA and testosterone changes in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after treatment with goserelin microspheres combined with novel hormonal agents (NHA).

A real-world observational study on the trends of PSA and testosterone changes in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after treatment with goserelin microspheres combined with novel hormonal agents (NHA).

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109081
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Prostate cancer

Interventions

goserelin microspheres+NHA treatment Group:None

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate, excluding small cell/neuroendocrine components. 2. Imaging suggests the presence of distant metastasis (excluding regional lymph node metastasis). 3. Patients planned to receive goserelin microspheres + NHA treatment can be enrolled, and those who will receive concurrent chemotherapy are also eligible. 4. Imaging evidence of distant metastasis. 5. Male patients aged >=18 years. 6. ECOG PS score of 0–1. 7. Patients voluntarily participate, are able to comply with regular follow-up, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous anti-tumor treatment for prostate cancer (including endocrine therapy, chemotherapy, etc.; patients who have undergone radical prostatectomy or radical radiotherapy for prostate cancer and subsequently developed metachronous metastasis are eligible). 2. Previous diagnosis of other malignancies. 3. Life expectancy< 1 year. 4. Other severe diseases, such as unstable cardiac disease after treatment, myocardial infarction within 6 months prior to treatment, cardiac function class 3–4 (NYHA), uncontrolled hypertension (greater than 150/90 mmHg) despite treatment; severe neurological or psychiatric disorders including dementia or epilepsy; uncontrolled active infection; acute gastric ulcer; hypercalcemia; chronic obstructive pulmonary disease requiring hospitalization, etc.

Design outcomes

Primary

MeasureTime frame
The proportion of patients whose PSA levels drop below 0.2 ng/mL within 6 months of starting treatment;

Secondary

MeasureTime frame
The proportion of patients whose testosterone levels drop to below 0.7/1.7 nmol/L within 1 year of starting treatment;Time from the start of treatment to PSA90/PSA50/PSA < 0.2 ng/ml; rate of 1 - year complete response of PSA;safety;Treatment adherence;

Countries

China

Contacts

Public ContactCao Yudong

Peking Cancer Hospital

ydcao@bjmu.edu.cn+86 10 8819 6064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026