Actively Recruiting
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 Metastatic Hormone-Sensitive Prostate Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-07-21
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying men with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) to compare two treatment durations of Rezvilutamide combined with androgen deprivation therapy (ADT) and chemotherapy. The study aims to determine if a 6-month course of Rezvilutamide is not worse than a longer-term treatment in improving the time patients live without their cancer getting worse on scans. It also looks at other outcomes like PSA progression, bone-related events, and quality of life. Participants will be randomly assigned to receive either a 6-month or a long-term course of Rezvilutamide alongside ADT and six cycles of docetaxel chemotherapy. The treatments are given as part of a triple therapy regimen, and the study is open-label, meaning both participants and researchers know which treatment is given. The trial lasts around three years, during which patients are monitored closely. Throughout the study, participants will have regular assessments including imaging to check cancer progression, blood tests to measure PSA levels, and evaluations of bone-related complications. Quality of life questionnaires will also be completed. Researchers will track the occurrence of side effects and measure how long patients remain free from disease progression. Follow-up visits will continue up to 36 months to gather comprehensive data on treatment impact and safety.
CONDITIONS
Brief Title
Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- High tumor burden defined by bone metastases (≥4 lesions with at least one outside pelvis or spine) or visceral metastases (excluding lymph nodes)
- Planned to receive or maintain androgen deprivation therapy with continuous LHRHa treatment or previous bilateral orchiectomy
- Planned to receive 6 cycles of docetaxel chemotherapy
- Meet specified organ function levels including blood counts, liver and kidney function, and heart ejection fraction ≥50%
- Able to comply with the trial protocol
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Prior treatments for prostate cancer including ADT over 3 months with disease progression, chemotherapy, surgery, or radiotherapy not meeting allowed exceptions
- Prior or planned use of second-generation androgen receptor antagonists or investigational testosterone synthesis inhibitors during study
- Use of certain medications within 4 weeks before study start including 5-alpha-reductase inhibitors, hormones, corticosteroids (except temporary allergy use), herbal anti-prostate cancer medicines
- Participation in other clinical trials with investigational treatments
- Presence of brain tumor lesions
- Planned to receive any other anticancer treatment during the trial
- Known allergy to apalutamide, ADT, or chemotherapy components
- Conditions affecting drug intake like swallowing disorders or intestinal issues
- History of seizures or conditions causing seizures within 12 months before study
- Active serious cardiac diseases within 6 months before study
- Other malignancies within 5 years except fully resolved or slow progressing ones
- Active hepatitis B or C infection with high viral load
- History of immunodeficiency or organ transplantation
- Unwillingness to use effective contraception during treatment and 30 days after
- Conditions posing serious risk or affecting ability to complete study such as uncontrolled hypertension, severe diabetes, neurological or psychiatric diseases
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months or long-term depending on assigned course
Participants receive either a 6-month or a long-term course of Rezvilutamide combined with androgen deprivation therapy (ADT) and chemotherapy.
Visits scheduled according to treatment cycles and assessments
Duration - Up to 36 months
Participants are monitored for radiographic progression-free survival, prostate-specific antigen progression, bone-related events, subsequent treatments, response rates, and quality of life for up to 36 months.
Regular visits for assessments throughout follow-up period
Trial Site Locations
Total: 1 location
1
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
S
Shangqian Wang, M.D.,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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