A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec

Study Identifier:
PrTK05
CT.gov Identifier:
NCT07332000
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: ACTIVE COMPARATOR: Control
    • Read More
  • Drug: External Beam Radiation Therapy (EBRT) alone
  • Drug: Drug: External Beam Radiation Therapy (EBRT)
  • Drug: Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)
  • Drug: EXPERIMENTAL: Treatment
  • Drug: Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT)
  • Drug: Drug: aglatimagene besadenovec + valacyclovir
  • Drug: aglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally.
  • Drug: Other Names: CAN-2409 plus prodrug
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 1. Participants must give study-specific informed consent prior to enrollment
    • 2. Histologically confirmed adenocarcinoma of the prostate
    • 3. Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
    • 4. Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)
    • 5. 18 years of age or older
    • 6. Performance status must be Eastern Cooperative Oncology Group 0-2
    • 7. The following laboratory criteria must be met (treatment group only):
    • 1. Aspartate aminotransferase (AST) < 3 x upper limit of normal
    • 2. Serum creatinine < 2 mg/dL
    • 3. Calculated creatinine clearance > 30 mL/min
    • 4. White blood cells > 3000/mm3
    • 5. Platelets >100,000/mm3
    Exclusion criteria
    • 1. Active liver disease, including known cirrhosis or active hepatitis
    • 2. Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
    • 3. Known HIV+ participants
    • 4. Regional lymph node involvement or distant metastases
    • 5. Participants planning to receive whole pelvic irradiation
    • 6. Other current malignancy (except squamous or basal cell skin cancers)
    • 7. Other serious co-morbid illness or compromised organ function that, in the opinion of the Investigator, would interfere with treatment or follow-up. For example, participants with diseases that preclude radiation therapy to the prostate such as severe prostatitis and inflammatory bowel disease.
    • 8. Prior treatment for prostate cancer except transurethral resection of the prostate (TURP). If prior TURP, participants must be deemed able to receive multiple intra-prostatic injections by the Investigator.
    • 9. Participants who had or plan to have orchiectomy as the form of hormonal ablation
    • 10. Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Status
    Recruiting
    Condition(s) Treated at Site
    Prostate