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Prostate Cancer Patients Treated by RadiotherapyGeneticsProstate healthCancerMen's healthBiologicalRadiationPhase 2

What this study is

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).

What's being tested

  • aglatimagene besadenovec + valacyclovir

    Intervention · BIOLOGICAL

    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.

  • External Beam Radiation Therapy (EBRT)

    Intervention · RADIATION

    Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)

Study details

Official title
A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec
Sponsor
Candel Therapeutics, Inc.
Conditions
Prostate Cancer Patients Treated by Radiotherapy · Prostate Cancer (Adenocarcinoma)
Enrolling
45 people
Starts
2025-10-30
Est. completion
2027-02
Design
Open-label, non-randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗