Back to resultsAn Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Primary Purpose
High-Risk and Oligometastatic Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apalutamide
Sponsored by
About this trial
This is an interventional treatment trial for High-Risk and Oligometastatic Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult males aged above 18 years old, no healthy volunteers included;
- Prostate cancer confirmed by pathological findings;
- High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
- Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
- ECOG score of 0 - 1
- Agreement to undergo preoperative and postoperative endocrine therapy;
- Voluntary signing of an ICF for the clinical trial
Exclusion Criteria:
- Any other tumor disease requiring treatment;
- Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
- A history of epilepsy or any condition that may lead to seizures;
- Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
high-risk and oligometastatic prostate cance
Arm Description
Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues
Outcomes
Primary Outcome Measures
rPFS
radiographic progression-free survival
Secondary Outcome Measures
pCR
pathological complete response
PFS
positive margin rate; progression-free survival
PSA response rate:
more than 50% decrease from baseline
TTPP
time to PSA progression
time to BCR after surgery
pathological stage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04997252
Brief Title
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Official Title
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-Risk and Oligometastatic Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-risk and oligometastatic prostate cance
Arm Type
Experimental
Arm Description
Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Intervention Description
apalutamide as neoadjuvant therapy
Primary Outcome Measure Information:
Title
rPFS
Description
radiographic progression-free survival
Time Frame
Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Secondary Outcome Measure Information:
Title
pCR
Description
pathological complete response
Time Frame
preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Title
PFS
Description
positive margin rate; progression-free survival
Time Frame
preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Title
PSA response rate:
Description
more than 50% decrease from baseline
Time Frame
preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Title
TTPP
Description
time to PSA progression
Time Frame
preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Title
time to BCR after surgery
Time Frame
preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Title
pathological stage
Time Frame
preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males aged above 18 years old, no healthy volunteers included;
Prostate cancer confirmed by pathological findings;
High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
ECOG score of 0 - 1
Agreement to undergo preoperative and postoperative endocrine therapy;
Voluntary signing of an ICF for the clinical trial
Exclusion Criteria:
Any other tumor disease requiring treatment;
Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
A history of epilepsy or any condition that may lead to seizures;
Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang yiming
Phone
020-62782726
Email
59281481@qq.com
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
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