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Prostate Cancer (Adenocarcinoma)Phase 2NCT06636682

FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer

A Phase 2 study testing FK-PC101 in people with Prostate Cancer (Adenocarcinoma) and Prostate CA, run by Cellvax Therapeutics Inc at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men only
What is being tested?
FK-PC101
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesUnited States
Study dates
14 Oct 2024to 4 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

FK-PC101 Trial Management contact

215-941-5916

FKPC101@cellvx.com

United States3 sites, 2 recruiting

  • University of Chicago Medicine, High-Risk and Advanced Prostate Cancer Clinic

    Chicago, Illinois, 60637

    Active, not recruiting

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

    Ronney Abaza, MD, 614-796-2842, dublinoffice@centralohiourology.com

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Neal Shore, MD, 843-839-1679, nshore@auclinics.com

    Recruiting

Other trials in United States

About this study

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

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?

Read more

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.

Read the 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.

Being tested
FK-PC101, Standard of Care (SOC)
Keywords
Vaccine, Prostatectomy, Autologous, Radical Prostatectomy
Medical subject headings
Prostatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FK-PC101Biological

    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).

  • Standard of Care (SOC)Biological

    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).

Study groups in NCT06636682
Study groupRoleWhat they receive
FK-PC101ExperimentalUp to 7 doses of intradermal FK-PC101 vaccine
Receives: Biological: FK-PC101
Standard of CareActive comparatorStandard of care, with possibility to cross-over to FK-PC101 vaccine should prostate cancer recur within 1 year of radical prostatectomy
Receives: Biological: Standard of Care (SOC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    DFS is defined as local prostate cancer recurrence, distant metastatic prostate cancer recurrence, biochemical recurrence of PSA, or death from any cause

    Measured: Up to approximately 22 months

Secondary outcomes (4)

  1. Time to next treatment (TTNT)

    Time from randomization until disease recurrence or receipt of any form of adjuvant or salvage radiotherapy, hormonal therapy including ADT, or any other form of prostate cancer therapy post-randomization

    Measured: Up to approximately 22 months

  2. Metastasis-free survival (MFS)

    Time from date of randomization to the 1st evidence of distant metastatic prostate cancer recurrence as detected by PSMA-PET/CT or other imaging performed, or to death from any cause

    Measured: Up to approximately 22 months

  3. Immune response to FK-PC101

    Immune response to FK-PC101 as measured by ELISpot assay (FK-PC101 arm only)

    Measured: From baseline until Month 22

  4. Safety and tolerability of FK-PC101

    Frequency and severity of AEs per the NCI-CTCAE version 5.0

    Measured: Up to approximately 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start14 Oct 2024
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion4 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636682
Sponsor's protocol ID
FK-PC101-01
Status last verified
Oct 2024
First submitted
8 Oct 2024
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FK-PC101 in people with Prostate Cancer (Adenocarcinoma) and Prostate CA, run by Cellvax Therapeutics Inc at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact FK-PC101 Trial Management (215-941-5916, FKPC101@cellvx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: Up to approximately 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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