Recruiting
Phase 2

Aglatimagene Besadenovec & Valacyclovir

Sponsor:

Candel Therapeutics, Inc.

Code:

NCT07332000

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

aglatimagene besadenovec + valacyclovir

External Beam Radiation Therapy (EBRT)

Study Details

Brief 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)

Study ID

NCT07332000

Start date

Oct 30, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants must give study-specific informed consent prior to enrollment
2. Histologically confirmed adenocarcinoma of the prostate
3. Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
4. 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)
5. 18 years of age or older
6. Performance status must be Eastern Cooperative Oncology Group 0-2
7. The following laboratory criteria must be met (treatment group only):

1. Aspartate aminotransferase (AST) < 3 x upper limit of normal
2. Serum creatinine < 2 mg/dL
3. Calculated creatinine clearance > 30 mL/min
4. White blood cells > 3000/mm3
5. Platelets >100,000/mm3

Exclusion Criteria:

1. Active liver disease, including known cirrhosis or active hepatitis
2. Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
3. Known HIV+ participants
4. Regional lymph node involvement or distant metastases
5. Participants planning to receive whole pelvic irradiation
6. Other current malignancy (except squamous or basal cell skin cancers)
7. 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.
8. 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.
9. Participants who had or plan to have orchiectomy as the form of hormonal ablation
10. Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)

Study Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment

Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT)

active comparator: Control

External Beam Radiation Therapy (EBRT) alone

Interventions

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.

External Beam Radiation Therapy (EBRT)

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Academic Urology and Urogynecology of Arizona

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Principal Investigator:

Chandan Kundavaram, M.D.

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

Principal Investigator:

Thomas Facelle, M.D.

Urology Associates

Recruiting

Littleton, Colorado, United States, 80122

Contacts

Principal Investigator:

James Fagelson, M.D.

Chesapeake Urology Research Associates

Recruiting

Towson, Maryland, United States, 21204

Contacts

Principal Investigator:

Ronald Tutrone, M.D.

Sheldon Freedman, MD Ltd.

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

Sheldon Freedman, M.D.

Summit Health

Recruiting

Saddle Brook, New Jersey, United States, 07663

Contacts

Michelle Mackenzie, RN OCN CCRC

973-436-1755Mmackenzie@summithealth.com

Principal Investigator:

Glen Gejerman, M.D.

START Carolinas

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Principal Investigator:

John Sylvester, M.D.

More Information

Sponsor

Candel Therapeutics, Inc.

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Biomarkers
  • Viral Shedding
  • Prostate Cancer
  • Aglatimagene Besadenovec

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Candel Therapeutics, Inc. on 2026-03-20.