Trial Title:
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
NCT ID:
NCT06636682
Condition:
Prostate Cancer (Adenocarcinoma)
Prostate CA
Prostate Cancers
Prostate Cancer (Post Prostatectomy)
Prostate Cancer
Prostate Cancer Patients Undergoing Radical Prostatectomy
High-risk Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Vaccine
Prostatectomy
Autologous
Radical Prostatectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
FK-PC101
Description:
Up to 7 doses of FK-PC101 will be administered intradermally between Day 1 and Day 180.
The immune adjuvant Bacillus Calmette Guérin (BCG) will be given concurrently with Dose 1
(day 1) and Dose 2 (day 8).
Arm group label:
FK-PC101
Intervention type:
Biological
Intervention name:
Standard of Care (SOC)
Description:
Subject receives Investigator-defined standard of care, excluding adjuvant therapy. If
prostate cancer recurs before 12 months after radical prostatectomy, subjects are
eligible to receive up to 7 doses of intradermal FK-PC101 vaccine (first 2 given
concurrently with BCG).
Arm group label:
Standard of Care
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.
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 subject's 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-RP/immediately prior to randomization.
Subjects will be randomized in a 1:1 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023
classification.
- Has ≥3 prostate biopsy cores with ≥50% tumor involvement.
- Has PSA >4 ng/mL ≤28 days prior to enrollment.
- Has no evidence of distant metastases based on PSMA-PET/CT performed ≤28 days prior
to enrollment.
- Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date
must be 3 to 14 days after enrollment.
- Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy,
androgen deprivation therapy (ADT), or any other anticancer therapy.
- Has a life expectancy >5 years.
Additional key eligibility criteria immediately postoperative for inclusion in the
randomized population include:
- Stage >pT3a (tumor has extended outside of the prostate on one side).
- Gleason score of 8, 9, or 10 (high/very high) on prostatectomy specimen.
- Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.
- Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging
permitted.
- Subjects must have negative surgical margins or microscopic-only positive surgical
margins.
Final eligibility criteria at 2 months postoperative for randomization include:
- FK-PC101 has been produced for the subject and meets all release specifications.
- An undetectable PSA (<0.04 ng/mL) on the most recent test performed prior to
randomization (Day -4 to -7).
- No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy
such as ADT, or any other anticancer therapy (future therapy should not be
administered until evidence exists of prostate cancer disease recurrence [such as
PSA recurrence]).
- Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1
(Day -14 to -7). Specific laboratory requirements include:
- Absolute neutrophil count (ANC) >1000/µL
- Platelet count >100,000/µL.
- Hemoglobin >8.0 gm/dL.
- Estimated glomerular filtration rate (eGFR) >60 mL/minute based on
Cockcroft-Gault formula.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both <2 ×
upper limit of normal (ULN).
- Albumin >3.0 gm/dL.
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions of the study.
Exclusion Criteria:
- Has an additional active malignancy that may confound the assessment of the study
endpoints. If the subject has a past cancer history (active malignancy within 2
years prior to study entry) with substantial potential for recurrence, this must be
discussed with the Sponsor before study entry. Note: Subjects with the following
concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and
carcinomas in situ (including breast DCIS, transitional cell carcinoma/NMIBC, anal
carcinoma, and melanoma in situ).
- Is eligible for and elects to receive adjuvant therapy following RP.
- Has clinically significant cardiovascular disease (e.g., uncontrolled or any New
York Heart Association [NYHA] Class 3 or 4 congestive heart failure, uncontrolled
angina, history of myocardial infarction, unstable angina, pulmonary embolism or
stroke within 6 months prior to study entry, uncontrolled hypertension, or
clinically significant arrhythmias not controlled by medication).
- Has uncontrolled, clinically significant pulmonary disease (e.g., chronic
obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the
Investigator would put the subject at significant risk for pulmonary complications
during the study.
- Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.
- Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic
treatment in the past 2 years (i.e., with use of disease-modifying agents,
corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that
function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid
gland (e.g., in Graves' disease) is not considered a form of systemic treatment of
an autoimmune disease.
- Is currently receiving systemic steroid therapy at a prednisone equivalent dose of
>10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7
days prior to enrollment.
- Has uncontrolled intercurrent illness including, but not limited to, uncontrolled
infection, disseminated intravascular coagulation, or psychiatric illness/social
situations that would limit compliance with study requirements.
- Is at risk for disseminated BCG infection or has previously demonstrated an allergic
response to BCG or its components.
- Has known positive status for human immunodeficiency virus (HIV) or active or
chronic Hepatitis (Hep) B or Hep C. Screening is not required.
- Has any medical condition which in the opinion of the Investigator places the
subject at an unacceptably high risk for toxicity.
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Chicago Medicine, High-Risk and Advanced Prostate Cancer Clinic
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Central Ohio Urology Group
Address:
City:
Gahanna
Zip:
43230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ronney Abaza, MD
Phone:
614-796-2842
Email:
dublinoffice@centralohiourology.com
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neal Shore, MD
Phone:
843-839-1679
Email:
nshore@auclinics.com
Start date:
October 14, 2024
Completion date:
May 4, 2027
Lead sponsor:
Agency:
Cellvax Therapeutics Inc
Agency class:
Industry
Source:
Cellvax Therapeutics Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636682
