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Genital Diseases, Male

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Male Urogenital Diseases

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Docetaxel

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Hormone Antagonists

Neoadjuvant chemotherapy combined with hormone therapy, Radical Prostatectomy (RP)+ extended lymph node dissection

Neoadjuvant hormonal therapy, radical Prostatectomy (RP)+ extended lymph node dissection.

Radical Prostatectomy (RP)+ extended lymph node dissection alone.

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

Neoadjuvant chemotherapy combined with hormone therapy

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

Neoadjuvant hormone therapy

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.

Radical Prostatectomy (RP)+ extended lymph node dissection

Wei Xue

Chenfei Chi

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.

Using larger sample prospective randomized controlled study design, and comparing neoadjuvant HT combined with docetaxel chemotherapy to neoadjuvant HT followed by RP and extended lymph node dissection to determine whether neoadjuvant HT combined with docetaxel chemotherapy can more effectively improve biochemical progression-free survival of locally advanced prostate cancer patients.

Further analysis was performed to determine whether the treatment regimen helped to prolong the radiologic progression-free survival (rPFS) or OS in these patients.

The pathological changes of tumor before and after neoadjuvant treatment were also analyzed. To search for the important risk factors influencing the long-term prognosis of these patients, the safety characteristics of patients in different treatment groups were analyzed. Therefore, it can provide the basis for the formulation of the optimal treatment plan for locally advanced prostate cancer, prolong the survival time of patients and improve the quality of life.

Study design: Prospective，Multicenter, Open-label, Parallel group, Randomized (2:2:1) Controlled , Clinical Trial

Study group: Newly diagnosed, untreated cT3a-cT4 or any cT, cN1 in locally advanced hormone-sensitive prostate cancer.

Study group number: 475 cases, Randomized 2:2:1

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

A Prospective, Multicenter, Three-arm, Randomized, Controlled Study Comparing the Efficacy of Neoadjuvant Hormonal Therapy Combined With Systemic Chemotherapy (NCHT), Neoadjuvant Hormonal Therapy (NHT) and Radical Prostatectomy Only in Locally Advanced Prostate Cancer

Biochemical recurrence-free survival (bPFS): defined as the time from randomization to biochemical recurrence. The definition of biochemical recurrence is as follows: in the case of normal testosterone levels, the PSA was \>0.2 ng/ml twice for more than 4 consecutive weeks.

The ratio of patients whose consecutive postoperative PSA \<0.2ng/ml within 1-year.

The time from randomization to death due to all causes.

The time from randomization to first confirmed imaging progression or death (whichever first is counted). Imaging progression was defined as one of the following: a. Progression of soft tissue lesions as defined in the revised RECIST 1.1 (Appendix 8) found by CT or MRI. b. Confirmation of bone metastasis lesions by ECT or PET-CT examination.

The time from randomization to the time when PSA increased by 25%.

The time from treatment to the time of ECOG score progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT04220398	Prostate Cancer Chemotherapy Ef... Hormone Sensiti... Locally Advance...	Neoadjuvant che... Neoadjuvant hor... Radical Prostat...	18 Years - 75 Years	RenJi Hospital
Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT04220398	Prostate Cancer Chemotherapy Ef... Hormone Sensiti... Locally Advance...	Neoadjuvant che... Neoadjuvant hor... Radical Prostat...	18 Years - 75 Years	RenJi Hospital

Spots Global Cancer Trial Database for neoadjuvant chemotherapy combined with hormone therapy