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A Retrospective Study of Neoadjuvant Chemotherapy for Newly Diagnosed Large-Volume ( >= 60 ml) Initially Deemed Unresectable Prostate Cancer

A Retrospective Study of Neoadjuvant Chemotherapy for Newly Diagnosed Large-Volume (>= 60 ml) Initially Deemed Unresectable Prostate Cancer - A multicenter real-world study evaluating the efficacy and safety of ADT combined with docetaxel before radical prostatectomy in the treatment of unresectable prostate cancer with a volume >= 60ml

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101068
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-04-20
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

prostate cancer

Interventions

investigation group:None

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1)Patients newly diagnosed with prostate cancer, pathologically confirmed as prostate adenocarcinoma. (2)According to the 2023 EAU Prostate Cancer Clinical Guidelines, the initial clinical stage at diagnosis is LAPC (locally advanced prostate cancer) or OMPC (oligometastatic prostate cancer), with SPECT showing no systemic metastasis or no more than 3 bone metastases. (3)Retrospective review of initial prostate MRI shows prostate volume >60ml, with both a senior radiologist and a senior urologist concluding that the prostate cancer severely invades surrounding organs such as the rectum or bladder, making complete resection of the primary prostate cancer and pelvic metastases impossible, or resulting in an extremely high risk of permanent urinary incontinence if resection is attempted. (4)The patient expresses willingness for RP (radical prostatectomy) and has received at least 3 cycles of preoperative A+D therapy. (5)Patients who did not undergo RP after completing A+D therapy are still included in the intention-to-treat analysis.

Exclusion criteria

Exclusion criteria: (1)Patients must be in the hormone-sensitive stage at the start of treatment, excluding m0-1CRPC (castration-resistant prostate cancer). (2)Patients with a history of surgeries such as transurethral resection of the prostate (TURP), which prevents assessment of prostate size changes before and after A+D conversion therapy. (3)Prostate biopsy results indicating neuroendocrine prostate cancer, including small cell carcinoma. (4)Patients receiving ADT alone, or ADT combined with novel endocrine therapies, or ADT combined with novel endocrine therapy and chemotherapy as other preoperative treatments. (5)Patients receiving fewer than 3 cycles of A+D therapy.

Design outcomes

Primary

MeasureTime frame
Conversion efficacy of preoperative ADT+Docetaxel therapy(A+D);

Secondary

MeasureTime frame
changes in primary prostate tumor volume;positive surgical margin rate;postoperative pathological characteristics;PSA change rate;perioperative complications;urinary continence status;severe adverse events during chemotherapy;

Countries

China

Contacts

Public ContactQi Ma

The First Affiliated Hospital of Ningbo University

fyymaqi@nbu.edu.cn+86 159 5880 0971

Outcome results

None listed

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