Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

All Drugs and Chemicals

Androgen Antagonists

Androgens

Hormones

Hormone Antagonists

6-month course of Rezvilutamide with ADT and chemotherapy

Long-term course of Rezvilutamide with ADT and chemotherapy

6-month course of Rezvilutamide and ADT + chemotherapy

6-month course of antiandrogen drugs

Long-term course of Rezvilutamide and ADT + chemotherapy

Long-term course of antiandrogen drugs

Shangqian Wang, M.D.,PhD

Shangqian Wang, M.D.,PhD.

Lixin Hua, M.D.

Lixxin Hua

Primary Objective:

To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC).

Secondary Objectives:

To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC.

To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC.

Exploratory Objectives:

To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.

Primary Study Endpoints:

Radiographic progression-free survival (rPFS)

Secondary Study Endpoints:

Time to prostate-specific antigen (PSA) progression Time to next bone-related event (including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones) Time to initiation of subsequent anti-prostate cancer treatment Objective response rate (ORR) Quality of life assessment scores

Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC

Time to PSA doubling on ADT + Rezvilutamide + Chemo

including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones

Bone related treatment; Radiation therapy

PSA response, tumor burden shrink on radiographic reports

Quality of life form with higher score indicating a better life experience under cancer condition

The First Affiliated Hospital with Nanjing Medical University

M.D.

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

Leuprolide

Goserelin

Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC

Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA \> 1ng/ml (or PSA \> 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.

Darolutamide continuous

Darolutamide intermittent

Shangqian Wang

To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.

Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment.

1. When the patient reaches:

1. PSA ≤ 0.2ng/ml
2. Or PSA \> 0.2ng/ml but with more that 90% decrease comparing baseline
3. Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA \> 1ng/ml (or PSA \> 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.

2. When the patient:

1. PSA \> 0.2ng/ml and has not decreased by 90% compared to baseline
2. Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC	NCT05956639	Metastatic Horm...	6-month course ... Long-term cours...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC	NCT05956639	Metastatic Horm...	6-month course ... Long-term cours...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC	NCT06177015	Metastatic Pros... Intermitent Ant...	Darolutamide co... Darolutamide in...	40 Years - 80 Years	The First Affiliated Hospital with Nanjing Medical University

Spots Global Cancer Trial Database for triple treatment regimen