A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT07332000
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prostate Cancer (Adenocarcinoma)
  • Prostate Cancer Patients Treated by Radiotherapy

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aglatimagene besadenovec + valacyclovir — 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) — RADIATION
    Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)

Study Details

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).

Key Dates

Start date
Oct 30, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment
    Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT)
  • Active Comparator: Control
    External Beam Radiation Therapy (EBRT) alone

Primary Outcome Measure

Biodistribution of aglatimagene besadenovec [ Time Frame: Up to 3 months post last injection of aglatimagene besadenovec. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Academic Urology and Urogynecology of ArizonaPeoriaArizona85381
Jennifer Hill
[email protected]
480-264-9958
Chandan Kundavaram, M.D. (PRINCIPAL_INVESTIGATOR)
Colorado Clinical ResearchLakewoodColorado80228
Stephanie Melgar-Donis
[email protected]
720-213-3130
Thomas Facelle, M.D. (PRINCIPAL_INVESTIGATOR)
Urology AssociatesLittletonColorado80122
Kim Ulibarri
[email protected]
303-733-8848
James Fagelson, M.D. (PRINCIPAL_INVESTIGATOR)
Chesapeake Urology Research AssociatesTowsonMaryland21204
Tenia Heigh
[email protected]
443-471-5750
Rayna B. Campbell
[email protected]
Ronald Tutrone, M.D. (PRINCIPAL_INVESTIGATOR)
Sheldon Freedman, MD Ltd.Las VegasNevada89144
Danielle Freedman
[email protected]
702-732-0282
Sheldon Freedman, M.D. (PRINCIPAL_INVESTIGATOR)
Summit HealthSaddle BrookNew Jersey07663
Michelle Mackenzie, RN OCN CCRC
[email protected]
973-436-1755
Glen Gejerman, M.D. (PRINCIPAL_INVESTIGATOR)
START CarolinasMyrtle BeachSouth Carolina29572
Matthew Parton
[email protected]
(843) 839-1679
Taylor Stephenson
[email protected]
(843) 839-1679
John Sylvester, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Academic Urology and Urogynecology of Arizona· Peoria, AZColorado Clinical Research· Lakewood, COUrology Associates· Littleton, COChesapeake Urology Research Associates· Towson, MDSheldon Freedman, MD Ltd.· Las Vegas, NVSummit Health· Saddle Brook, NJ

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