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

Inclusion Criteria12

Participants must give study-specific informed consent prior to enrollment
Histologically confirmed adenocarcinoma of the prostate
Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
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)
years of age or older
Performance status must be Eastern Cooperative Oncology Group 0-2
The following laboratory criteria must be met (treatment group only):
Aspartate aminotransferase (AST) \< 3 x upper limit of normal
Serum creatinine \< 2 mg/dL
Calculated creatinine clearance \> 30 mL/min
White blood cells \> 3000/mm3
Platelets \>100,000/mm3

Exclusion Criteria10

Active liver disease, including known cirrhosis or active hepatitis
Participants on systemic corticosteroids (\> 10 mg prednisone per day) or other immunosuppressive drugs
Known HIV+ participants
Regional lymph node involvement or distant metastases
Participants planning to receive whole pelvic irradiation
Other current malignancy (except squamous or basal cell skin cancers)
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.
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.
Participants who had or plan to have orchiectomy as the form of hormonal ablation
Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)

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)