Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636682
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Adaptive Phase 2 Randomized Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to learn if the vaccine FK-PC101 works to delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate cancer It will also learn about the safety of FK-PC101 The main questions it aims to answer are
Does FK-PC101 delay or prevent the return of prostate cancer following surgery What medical problems do participants subjects have when taking FK-PC101
Researchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor
Subjects will
Have a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer
If randomly selected to receive the vaccine subjects will receive the vaccine up to 7 times over a 6-month period
In addition to the treatment visits for those randomized to receive FK-PC101 there will be up to 4 follow up visits to the clinic over a 22-month nearly 2 year period
For subjects randomized to receive current treatment practice they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer Should their prostate cancer return within a year following surgery they will be eligible to receive FK-PC101 which already had been produced and thus no additional tumor tissue would need to be obtained
Subjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned
Does FK-PC101 delay or prevent the return of prostate cancer following surgery What medical problems do participants subjects have when taking FK-PC101
Researchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor
Subjects will
Have a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer
If randomly selected to receive the vaccine subjects will receive the vaccine up to 7 times over a 6-month period
In addition to the treatment visits for those randomized to receive FK-PC101 there will be up to 4 follow up visits to the clinic over a 22-month nearly 2 year period
For subjects randomized to receive current treatment practice they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer Should their prostate cancer return within a year following surgery they will be eligible to receive FK-PC101 which already had been produced and thus no additional tumor tissue would need to be obtained
Subjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned
Detailed Description:
This is a multicenter adaptive Phase 2 randomized open-label study designed to evaluate the efficacy of FK-PC101 adjuvant therapy in men with localized prostate cancer who have undergone radical prostatectomy RP Subjects will undergo a 3-step screening and enrollment process Following an initial safety run-in that will include at least three subjects assigned to receive FK-PC101 vaccine and monitored closely for safety subjects randomized to the vaccine group will receive up to 7 doses of FK-PC101 starting at 2 months post-RP Subjects in the control group will receive standard-of-care All subjects will have assessments at 60 days 2 months 90 days 3 months and 180 days 6 months and then continue with follow-up visits at 10 14 18 and 22 months after randomization
FK-PC101 is an autologous cellular vaccine with each product being manufactured from a portion of tumor from each subjects prostatectomy specimen The primary endpoint of DFS will be compared with the control group who will also meet all eligibility criteria but who do not receive any postoperative adjuvant therapy
Subjects will undergo a three-step eligibility process with criteria prior to RP immediately following RP and 2 months post-RPimmediately prior to randomization
Subjects will be randomized in a 11 open-label fashion to the vaccine group and the control group Subjects will be stratified based on pathologic nodal status pN0 vs pN1 Subjects in the vaccine group will initiate vaccine dosing with up to 7 doses given between Day 1 and Day 180 on Days 1 8 15 22 60 90 and 180 Subjects randomized to the control group will be followed through 8 follow-up visits through month 22 2 years post-surgery
Following disease recurrence all subjects may be treated with other prostate cancer therapies as deemed appropriate Subjects in the control group will be eligible to receive their vaccine after disease recurrence has been documented For subjects in the control group who elect to receive their vaccine it must be started within 1 year of randomization The vaccine doses may be administered prior to during or following other prostate cancer therapies but will follow the same schedule as for the subjects in the vaccine group
FK-PC101 is an autologous cellular vaccine with each product being manufactured from a portion of tumor from each subjects prostatectomy specimen The primary endpoint of DFS will be compared with the control group who will also meet all eligibility criteria but who do not receive any postoperative adjuvant therapy
Subjects will undergo a three-step eligibility process with criteria prior to RP immediately following RP and 2 months post-RPimmediately prior to randomization
Subjects will be randomized in a 11 open-label fashion to the vaccine group and the control group Subjects will be stratified based on pathologic nodal status pN0 vs pN1 Subjects in the vaccine group will initiate vaccine dosing with up to 7 doses given between Day 1 and Day 180 on Days 1 8 15 22 60 90 and 180 Subjects randomized to the control group will be followed through 8 follow-up visits through month 22 2 years post-surgery
Following disease recurrence all subjects may be treated with other prostate cancer therapies as deemed appropriate Subjects in the control group will be eligible to receive their vaccine after disease recurrence has been documented For subjects in the control group who elect to receive their vaccine it must be started within 1 year of randomization The vaccine doses may be administered prior to during or following other prostate cancer therapies but will follow the same schedule as for the subjects in the vaccine group
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