Trial Title:
Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC
NCT ID:
NCT05956639
Condition:
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Conditions: Official terms:
Hypersensitivity
Androgen Antagonists
Conditions: Keywords:
Triple treatment regimen
mHPSC
Rezvilutamide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
6-month course of antiandrogen drugs
Description:
6-month course of Rezvilutamide and ADT + chemotherapy
Arm group label:
6-month course of Rezvilutamide
Other name:
Rezvilutamide
Intervention type:
Drug
Intervention name:
Long-term course of antiandrogen drugs
Description:
Long-term course of Rezvilutamide and ADT + chemotherapy
Arm group label:
Long-term course of Rezvilutamide
Other name:
Rezvilutamide
Summary:
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.
Detailed description:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Inclusion criteria:
1. Age ≥ 18 years, male.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
3. Histologically or cytologically confirmed prostate adenocarcinoma without
evidence of neuroendocrine or small cell features.
4. High tumor burden, defined as having at least one of the following conditions:
1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside
the pelvis or spine). 2) CT/MRI revealing visceral metastatic lesions
(excluding lymph nodes).
5. Planned to receive or maintain androgen deprivation therapy (ADT) during the
study period, either by continuous LHRHa treatment or previous bilateral
orchiectomy (surgical castration), concurrently with 6 cycles of docetaxel
chemotherapy.
6. Organ function levels must meet the following requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
- Platelets (PLT) ≥ 100 × 10^9/L.
- Hemoglobin (Hb) ≥ 90 g/L.
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- Blood urea nitrogen (BUN) (or urea) and creatinine (Cr) ≤ 1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
7. Judged by the investigator to be able to comply with the trial protocol.
8. Voluntarily participate in the clinical trial, understand the study procedures,
and have signed the informed consent form.
Exclusion Criteria:
1. Prior treatment with ADT, chemotherapy, surgery, external beam radiation therapy,
brachytherapy, radiopharmaceuticals, or investigational local therapies for prostate
pain. However, the following cases are allowed for inclusion:
- Up to 3 months of ADT (medical or surgical castration) with or without
antiandrogen therapy prior to Cycle 1 Day 1 (C1D1) without evidence of
radiographic disease progression (based on RECIST 1.1 criteria) or clinically
significant PSA rise (defined as ≥50% increase from the lowest level after
reaching castration levels of serum testosterone) before C1D1.
- Transurethral prostatectomy or up to one course of palliative radiation therapy
or surgery for symptomatic treatment of metastatic disease at least 4 weeks
prior to C1D1. All adverse events related to these treatments must have
improved to at least Grade 1 (according to NCI-CTCAE v4.03) before starting
study treatment.
2. Prior use or planned use of second-generation androgen receptor antagonists (such as
enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other
investigational drugs inhibiting testosterone synthesis for the treatment of
prostate cancer during the study period.
3. Received the following treatments within 4 weeks before C1D1:
- 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride).
- Estrogens, progestins, androgens, systemic corticosteroids (except for
temporary use for allergic purposes).
- Known herbal medicines with anti-prostate cancer or PSA-lowering effects (e.g.,
saw palmetto).
- Participation in other clinical trials involving investigational treatments.
4. Confirmed brain tumor lesions on imaging.
5. Planned to receive any other anticancer treatment during the trial.
6. Known allergy or hypersensitivity to apalutamide, ADT, or chemotherapy components.
7. Presence of conditions that impede swallowing, chronic diarrhea, intestinal
obstruction, or other factors affecting drug intake and absorption.
8. History of seizures or occurrence of conditions that can induce seizures within 12
months before C1D1 (including transient ischemic attack, stroke, traumatic brain
injury with altered consciousness requiring hospitalization).
9. Presence of active cardiac diseases within 6 months before C1D1, including
severe/unstable angina, myocardial infarction, symptomatic congestive heart failure,
and ventricular arrhythmias requiring medication.
10. Diagnosis of any other malignancy within 5 years before C1D1, except for completely
resolved in situ cancer or malignancies with slow progression as determined by the
investigator.
11. Active HBV or HCV infection (HBV viral load ≥ 10,000 copies/mL, HCV viral load ≥
1,000 copies/mL).
12. History of immunodeficiency (including positive HIV test) or organ transplantation.
13. Unwillingness to use effective contraception during the entire study treatment
period and for 30 days after the last dose.
14. Judged by the investigator to have conditions that pose a serious risk to patient
safety, may confound study results, or may affect the patient's ability to complete
the study (such as poorly controlled hypertension, severe diabetes, neurological or
psychiatric diseases, etc.), or any other relevant circumstances.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Shangqian Wang, M.D.,PhD.
Phone:
68303186
Email:
wsq5501@126.com
Investigator:
Last name:
Lixin Hua, M.D.
Email:
Principal Investigator
Start date:
June 20, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05956639
