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Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer

NCT04220398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2020-01-07

No results posted yet for this study

Summary

To evaluate of the value of radical prostatectomy and extended pelvic lymph node dissection in locally advanced prostate cancer after neoadjuvant hormonal therapy with or without docetaxel chemotherapy.

Conditions

  • Prostate Cancer
  • Chemotherapy Effect
  • Hormone Sensitive Prostate Cancer
  • Locally Advanced Prostate Carcinoma

Interventions

DRUG

Neoadjuvant chemotherapy combined with hormone therapy

Docetaxel 75mg/m2 IV (every 3 weeks) +Prednisone 5mg BID orally + HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 4-6 cycles

DRUG

Neoadjuvant hormone therapy

HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 3-6 cycles

PROCEDURE

Radical Prostatectomy (RP)+ extended lymph node dissection

Radical Prostatectomy (RP)+ extended lymph node dissection: Within three months after neoadjuvant treatment. Treatment after prostatectomy: There will not have any drug treatment after surgery until disease progression. Pelvic lymph node dissection is required to reach the level of bilateral iliac artery. If the postoperative pathology indicated positive incisional margin or pelvic lymph node metastasis, pelvic adjuvant radiotherapy should be performed within 3 months after surgery.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2022-12-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220398 on ClinicalTrials.gov