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

NCT07332000 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-20

No results posted yet for this 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).

Conditions

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

Interventions

BIOLOGICAL

aglatimagene besadenovec + valacyclovir

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.

RADIATION

External Beam Radiation Therapy (EBRT)

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

Sponsors & Collaborators

  • Candel Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07332000 on ClinicalTrials.gov