Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528210
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-30
Brief Title:
Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-Arm Open-Label Phase II Study of Pembrolizumab Plus Androgen Deprivation Therapy ADT in Combination With Radiotherapy RT for High Risk Localized Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well pembrolizumab along with standard of care androgen deprivation therapy with bicalutamide and gonadotropin releasing hormone agonist and radiotherapy for the treatment of patients with high risk prostate cancer that has not spread to other parts of the body localized A monoclonal antibody such as pembrolizumab is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Bicalutamide is in a class of medications called androgen receptor inhibitors It works by blocking the effects of androgen a male reproductive hormone to stop the growth and spread of tumor cells Gonadotropin-releasing hormone agonists prevent the body from making luteinizing hormone-releasing hormone LHRH and luteinizing hormone LH This causes the testicles to stop making testosterone a male hormone in men and may stop the growth of prostate cancer cells that need testosterone to grow Radiation therapy uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumors Giving pembrolizumab with androgen deprivation therapy and radiotherapy may kill more tumor cells in patients with high risk localized prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the rate of prostate biopsy positivity at 6 months mo in patients receiving pembrolizumab plus androgen deprivation therapy ADT in combination with radiotherapy
II Determine the safety of pembrolizumab in combination with ADT and radiotherapy
SECONDARY OBJECTIVES
I Compare 6-month post-treatment biopsy positive rate in patients stratified by pre-treatment prostate infiltrating T-cell PD-1 and PD-L1 expression
II Measures changes in health related quality of life HRQOL III Determine the rate of grade 3 or higher Immune-related adverse events irAEs
IV Determine the rate of biochemical relapse-free survival bRFS stratified by tumor PD-1 and PD-L1 expression
EXPLORATORY OBJECTIVES
I Determine the time to cancer-directed treatment in subjects undergoing experimental treatment
II Determine the 5-year rate of biochemical relapse-free survival bRFS ie prostate specific antigen PSA nadir 2 ngmL III Determine the nadir biochemical response rate nadir PSA 05 ngmL IV Determine the clinical and bRFS at five years V Report safety and tolerability of pembrolizumab defined as pembrolizumab related adverse event of any grade and drug dose modification
VI Determine metastases-free survival based on conventional imaging not positron emission tomography PET based
VII Determine the serum castration recovery rate testosterone above 50 ngdL VIII Determine the serum testosterone recovery rate testosterone above 200 ngdL IX Assess the effect of pembrolizumab combined with ADT radiation therapy RT on serum blood and tissue markers of the immune response
X Correlate changes in markers of inflammatory response with clinical outcomes including post-treatment biopsy rate PSA response and tumor free survival
XI Correlate baseline prostate specific membrane antigen PSMA scan findings with efficacy endpoints
XII Changes from pre- to post-treatment serum peripheral blood mononuclear cells PBMC blood microbial and tissue markers of the immune response
XIII Correlation of changes in markers of inflammatory response with clinical outcomes including biopsy-complete response PSA response and disease free survival
XIV Determine the rate of local tumor eradication at 12 months for those who had persistent tumor at 6 months
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 3 weeks for 51 weeks in the absence of disease progression or unacceptable toxicity Patients receive standard of care GNRH agonist therapy for a total of 24 months bicalutamide orally PO once per day QD for 6 months or up to 24 months per the discretion of the treating physician and radiation therapy per standard of care Treatment is given in the absence of disease progression or unacceptable toxicity Patients undergo bone scan andor computed tomography CT scan magnetic resonance imaging MRI during screening and prostate biopsy and blood sample collection throughout the study
After completion of study therapy patients are followed up at 30 days and yearly thereafter
I Determine the rate of prostate biopsy positivity at 6 months mo in patients receiving pembrolizumab plus androgen deprivation therapy ADT in combination with radiotherapy
II Determine the safety of pembrolizumab in combination with ADT and radiotherapy
SECONDARY OBJECTIVES
I Compare 6-month post-treatment biopsy positive rate in patients stratified by pre-treatment prostate infiltrating T-cell PD-1 and PD-L1 expression
II Measures changes in health related quality of life HRQOL III Determine the rate of grade 3 or higher Immune-related adverse events irAEs
IV Determine the rate of biochemical relapse-free survival bRFS stratified by tumor PD-1 and PD-L1 expression
EXPLORATORY OBJECTIVES
I Determine the time to cancer-directed treatment in subjects undergoing experimental treatment
II Determine the 5-year rate of biochemical relapse-free survival bRFS ie prostate specific antigen PSA nadir 2 ngmL III Determine the nadir biochemical response rate nadir PSA 05 ngmL IV Determine the clinical and bRFS at five years V Report safety and tolerability of pembrolizumab defined as pembrolizumab related adverse event of any grade and drug dose modification
VI Determine metastases-free survival based on conventional imaging not positron emission tomography PET based
VII Determine the serum castration recovery rate testosterone above 50 ngdL VIII Determine the serum testosterone recovery rate testosterone above 200 ngdL IX Assess the effect of pembrolizumab combined with ADT radiation therapy RT on serum blood and tissue markers of the immune response
X Correlate changes in markers of inflammatory response with clinical outcomes including post-treatment biopsy rate PSA response and tumor free survival
XI Correlate baseline prostate specific membrane antigen PSMA scan findings with efficacy endpoints
XII Changes from pre- to post-treatment serum peripheral blood mononuclear cells PBMC blood microbial and tissue markers of the immune response
XIII Correlation of changes in markers of inflammatory response with clinical outcomes including biopsy-complete response PSA response and disease free survival
XIV Determine the rate of local tumor eradication at 12 months for those who had persistent tumor at 6 months
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 3 weeks for 51 weeks in the absence of disease progression or unacceptable toxicity Patients receive standard of care GNRH agonist therapy for a total of 24 months bicalutamide orally PO once per day QD for 6 months or up to 24 months per the discretion of the treating physician and radiation therapy per standard of care Treatment is given in the absence of disease progression or unacceptable toxicity Patients undergo bone scan andor computed tomography CT scan magnetic resonance imaging MRI during screening and prostate biopsy and blood sample collection throughout the study
After completion of study therapy patients are followed up at 30 days and yearly thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None