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

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Abiraterone Acetate

Prednisolone

Olaparib

Fluzoparib

Leuprolide

Methylprednisolone

Goserelin

Pamiparib

Triptorelin Pamoate

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.

1000 mg (250 mg×4 tablets) once daily, orally

Prednisolone tablets

160 mg (40 mg× 4 tablets) once daily, orally.

Enzalutamide

240 mg (60 mg×4 tablets) once daily, orally.

Apalutamide

600 mg (300 mg × 2 tablets) twice daily, orally.

Darotamide

240 mg (80 mg × 3 tablets) once daily orally

Rezvilutamide

The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.

PARP inhibitor

Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Robot-assisted radical prostatectomy

Junlong Zhuang, MD

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate

Biochemical progression free survival (bPFS) within 3 years

Metastasis-Free Survival (MFS) after intense neoadjuvant therapy

Time to castration-resistant prostate cancer（CRPC) after intense neoadjuvant therapy

Prostate specific antigen (PSA) drops ≥ 98% after intense neoadjuvant therapy

The positive margin rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy

The pathologic downgrade rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy compared with initial T stage.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. All grades of adverse events will be documented.

Spots Global Cancer Trial Database for intense endocrine therapy