- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05461261
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer
October 21, 2022 updated by: Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation
This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shun Zhang, MD
- Phone Number: 15050589789
- Email: explorershun@126.com
Study Contact Backup
- Name: Hongqian Guo, MD
- Email: dr.ghq@nju.edu.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Recruiting
- Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
-
Contact:
- Shun Zhang
- Phone Number: 15050589789 15050589789
- Email: explorershun@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Patients must be ≥ 40 and ≤75 years of age.
- All patients must have been histologically diagnozed of prostate cancer.
- Metastatic disease confirmed by imaging: positive bone scan, or soft tissue or visceral metastases confirmed by abdominal/pelvic/chest contrast CT or MRI or PSMA PET-CT scan.
- Participants who were treated with androgen deprivation therapy (ADT) (LHRH agonist/antagonist or orchectomy) with or without first-generation anti-androgens within 12 weeks prior to random assignment must maintain serum testosterone castration levels, i.e., ≤50 ng/dL (≤ 1.75 nmol/L) during the study period. First-generation anti-androgens must be discontinued at least 1 day before the start of study therapy.
- Participants must carry one of the following DNA repair gene mutation: 1) HRR-related genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L; 2) Lynch syndrome-related genes: EPCAM, MLH1, MSH2, MSH6, PMS2.
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤1.
- Patients must have adequate hematologic function, hepatic function and renal function within 28 days prior to registration.
- Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
- Sexually active male subjects and their partner must agree the use of condoms as an effective contraceptive method and to avoid sperm donation during the whole treatment and within 4 weeks after the end of treatment.
Exclusion Criteria:
- Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- Patients with brain/meningeal metastases are not eligible..
- Patients previously received any of the following treatments are not eligible: 1) LHRH agonists/antagonists within 12 weeks prior to the start of study therapy; 2) Second generation androgen receptor (AR) inhibitors, such as enzaluamine, dalotamide, apatamide, etc; 3) Cytochrome P17 enzyme inhibitors (e.g., abiraterone acetate or oral ketoconazole) as antitumor therapy for PCa; 4) Chemotherapy (including docetaxel) or immunotherapy for PCa; 5) Systemic corticosteroids > 10 mg/day equivalent dose of prednisone within 28 days prior to random assignment.
- Patients who were known to have hypersensitivity to any research drug or similar drug are not eligible.
- Patients received local treatments such as pre-focal treatment,radiotherapy and palliative endoscopic resection
- Patients with severe or uncontrolled concurrent infections are not eligible.
- Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
- Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
- Patients with mental illness, mental disability or inability to give informed consent are not eligible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel plus platinum
Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles.
|
Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles.
5mg Prednisolone Acetate will be given orally twice a day during treatment.
Platinum-based drugs will be given intravenously 70 mg/m2 every 3 weeks for 6 cycles.
Cisplatin or carboplatin will be carefully chosen according to each patient's Creatinine Clearance.
|
Active Comparator: Docetaxel alone
Docetaxel alone will be applied every 3 weeks for 6 cycles.
|
Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles.
5mg Prednisolone Acetate will be given orally twice a day during treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Time Frame: up to 3 years
|
Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC.
1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG.
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: up to 5 years
|
The survival rate of participants during follow-up time.
|
up to 5 years
|
rPFS
Time Frame: up to 5 years
|
Radiographic progression-free survival.
The survival of participants without radiographic progression.
|
up to 5 years
|
Time to PSA progression
Time Frame: up to 5 years
|
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
|
up to 5 years
|
Time to subsequent anti-tumor therapy
Time Frame: up to 5 years
|
Time from end of treatment to the time when subsequent anti-tumor therapy is needed.
|
up to 5 years
|
Adverse events
Time Frame: up to 3 years
|
All grades of adverse events will be recorded according to NCI CTCAE (v.5.0)
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hongqian Guo, Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University Locations: China, Jiangsu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Anticipated)
June 30, 2025
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
July 13, 2022
First Submitted That Met QC Criteria
July 13, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
October 24, 2022
Last Update Submitted That Met QC Criteria
October 21, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Hypersensitivity
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Docetaxel
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- IUNU-PC-114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy Effect
-
Hospices Civils de LyonCompletedChemotherapy Effect | G-CHOP Chemotherapy | R-CHOP ChemotherapyFrance
-
Namik Kemal UniversityCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingChemotherapy EffectFrance
-
West Cancer CenterPfizer; Emory UniversityCompletedChemotherapy EffectUnited States
-
Rennes University HospitalNot yet recruitingChemotherapy Effect | AplasiaFrance
-
Groupe Hospitalier Paris Saint JosephHopital Antoine BeclereCompletedCancer | Chemotherapy EffectFrance
-
Animated Dynamics, Inc.Purdue UniversityNot yet recruitingCancer | Chemotherapy EffectUnited States
-
Udayana UniversityUnknown
-
Sutter HealthUnknownChemotherapy Effect | Chemotherapeutic Toxicity | FastingUnited States
-
The Christie NHS Foundation TrustUniversity of ManchesterTerminated
Clinical Trials on Docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompleted
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom