- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249712
Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer
Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hongqian Guo, PhD
- Phone Number: +86-13605171690
- Email: dr.ghq@nju.edu.cn
Study Contact Backup
- Name: Shun Zhang, PhD
- Phone Number: +86-15050589789
- Email: explorershun@126.com
Study Locations
-
-
Jiangsu
-
Nanning, Jiangsu, China
- Recruiting
- Hongqian Guo
-
Contact:
- Hongqian Guo, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must be ≥ 18 and ≤75 years of age;
- All patients must have a histologically or cytologically diagnosis of prostate cancer,without distant metastasis, and suitable for radical prostatectomy;
All patients meet at least one of the following criteria:
- multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3;
- Gleason score of primary tumor ≥ 8;
- prostate specific antigen (PSA) ≥20 ng/ml; d) Radiographic assessment of regional lymph node metastases (N1);
- Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1;
- Patients must have adequate organ function: hematologic function:within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 / L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9 g / dL and international normalized ratio (INR) < 1.5; renal function:within 28 days prior to registration, as evidenced by serum creatinine ≤2×ULN; hepatic function: within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN;
- 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.
- Patients of childbearing potential must be willing to take high-efficiency contraceptive measures during the study period and within 120 days after the last dose of treatment.
Exclusion Criteria:
- Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
- Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3, Gleason score of primary tumor < 8, and prostate specific antigen (PSA)。
- Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases are not eligible.(any M1)。
- Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy are not eligible
- 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.
- The patient is mentally ill, mentally disabled or incapable of giving informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADT with Darolutamide
Pathological response rate after radical prostatectomy with dalotamide combined with androgen deprivation therapy (ADT) in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer. Duration of treatment: 28-day cycle of darotamide treatment and 6 cycles of neoadjuvant therapy. ADT treatment continued during neoadjuvant therapy and was discontinued after surgery. Adjusted dosing: When the serum testosterone concentration cannot be maintained at <50 ng/dL, the dose and type of ADT can be adjusted. Investigators can adjust the dose of darostatide according to the situation. |
600 mg (300 mg × 2 tablets) twice daily with meals, equivalent to a total daily dose of 1200 mg.
Other Names:
The ADT regimen used by each patient will be determined by the investigator, and the dose and frequency of administration will be consistent with the prescribing information.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological Response Rate (pCR or MRD)
Time Frame: up to 8months
|
Pathological Response Rate is defined as the pCR(Pathologic Complete Response Rate) or MRD (Proportion of Subjects With Minimal Residual Disease) Pathologic Complete Response Rate is defined as the proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Proportion of Subjects With Minimal Residual Disease is defined as the proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy or residual cancer burden <0.25cm3. |
up to 8months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AEs/SAEs
Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
|
The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug. The level of complications defined by Clavien-Dindo classification. |
Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
|
PSA biochemical progression-free survival rate
Time Frame: 3 years
|
Defined as the proportion of patients who did not experience biochemical progression or death within 3 years of initiation of darotamide treatment; biochemical progression was defined as an increase in serum PSA level to >0.2 ng/ml with 2 consecutive increases at least 3 months apart
|
3 years
|
Rate of Positive Surgical Margins
Time Frame: up to 8 months
|
The proportion of subjects with positive surgical margins after radical prostatectomy
|
up to 8 months
|
Rate of Stage Degradation
Time Frame: up to 8 months
|
The proportion of subjects whose tumor clinical or pathological stage degradation after neoadjuvant therapy.
|
up to 8 months
|
PSA response rate
Time Frame: up to 2 years
|
The proportion of subjects with a ≥98% reduction in nadir PSA from baseline PSA during neoadjuvant therapy
|
up to 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Quality of Life as assessed by FACT-P
Time Frame: up to 2 years
|
Defined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire
|
up to 2 years
|
Change From Baseline in Quality of life as assessed by BPI-SF
Time Frame: up to 2 years
|
Defined by worst pain item based on BPI-SF questionnaire.
|
up to 2 years
|
Change From Baseline in Quality of life as assessed by EPIC-26
Time Frame: up to 2 years
|
Defined by EPIC-26 questionnaire.
|
up to 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hongqian Guo, Phd, Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUNU-PC-112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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