Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Reproductive Control Agents

Docetaxel

Androgens

Hormones

Prednisone

Prolactin Release-Inhibiting Factors

Triptorelin Pamoate

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.

All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks.

75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy

Docetaxel injection

Triptorelin Pamoate for Injectable Suspension

5 mg oral low dose prednisone, once daily

Prednisone Acetate Tablets

Hongqian Guo, MD

This randomized, controlled, single center clinical trial aims to evaluate the efficacy and safety of Androgen Deprivation Therapy Combined with Docetaxel for High Risk Prostate Cancer with a six-month treatment cycle.

Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer

The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.

The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.

Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.

The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm.

Clinical or pathological stage degradation after neoadjuvant therapy

The proportion of subjects with positive surgical margins after radical prostatectomy.

The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment.

The operative time(min) of radical prostatectomy.

Estimated blood loss (ml) during the process of radical prostatectomy.

The hospitalization time, recorded in day.

Length of drainage duration, recorded in day.

The proportion of subjects who suffer from major complications.

The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.

Biochemical progression was defined as two consecutive rising PSA values that were above 0.2ng/ml at least one month apart, or starting adjuvant therapy after surgery including radiotherapy, ADT or anti-androgen therapy. The time for bPFS was measured from randomization to biochemical progression or death from any cause.

Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.

Serum complete response rate, defined as the proportion of participants with PSA ≤ 0.1 ng/mL after 6-month neoadjuvant therapy.

The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.

The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.

Spots Global Cancer Trial Database for triptorelin pamoate for injectable suspension