Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer

Hongqian Guo

Status and phase: Unknown; Phase 2

Conditions: Neoadjuvant Therapy \High Risk Prostate Cancer

Treatments: Other: placebo; Drug: Proxalutamide

Study type: Interventional

Funder types: Other

Identifiers

NCT05076851

IIT-GT0918-CN-1008

Details and patient eligibility

About

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,

Enrollment: 2 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
2. Patients must be ≥ 18，male
3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
6. ECOG PS：0-1

Exclusion criteria

1. Imaging or biopsy confirmed distant Metastatic lesion
2. The number of regional lymph nodes metastasis >3
3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

placebo+ADT

Treatment:

Other: placebo

Proxalutamide

Experimental group

Description:

Proxalutamide +ADT

Treatment:

Drug: Proxalutamide