RecruitingPhase 2NCT07332000

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

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

Sponsor

Candel Therapeutics, Inc.

Enrollment

45 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Adenocarcinoma)Prostate Cancer Patients Treated by Radiotherapy

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at biomarkers (biological signals in the body) in men with prostate cancer who are being treated with a new drug called aglatimagene besadenovec combined with standard radiation therapy. The goal is to better understand how the treatment works at a molecular level. **You may be eligible if...** - You are 18 or older and male - You have been diagnosed with intermediate-risk prostate cancer (confirmed by biopsy) - You are planning to receive standard external beam radiation therapy for prostate cancer - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - You have active liver disease, cirrhosis, or active hepatitis - You take high-dose steroids or other immune-suppressing drugs - You are HIV-positive - Your cancer has spread to lymph nodes or other parts of the body - You are planning hormone therapy (ADT) alongside radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALaglatimagene 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.

RADIATIONExternal Beam Radiation Therapy (EBRT)

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