What this study is
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).
What's being tested
- aglatimagene besadenovec + valacyclovir
Intervention · 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)
Intervention · RADIATION
Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)
Study details
- Official title
- A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec
- Sponsor
- Candel Therapeutics, Inc.
- Conditions
- Prostate Cancer Patients Treated by Radiotherapy · Prostate Cancer (Adenocarcinoma)
- Enrolling
- 45 people
- Starts
- 2025-10-30
- Est. completion
- 2027-02
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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)
- 18 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openAcademic Urology and Urogynecology of Arizona
Peoria, Arizona, United States
- Jennifer Hill · Contact480-264-9958jhill@academic-urology.com
- Chandan Kundavaram, M.D. · Principal investigator
RecruitingColorado Clinical Research
Lakewood, Colorado, United States
- Stephanie Melgar-Donis · Contact720-213-3130Stephanie.melgar-donis@coloradouro.com
- Thomas Facelle, M.D. · Principal investigator
RecruitingUrology Associates
Littleton, Colorado, United States
- Kim Ulibarri · Contact303-733-8848 ext. 1615kimberly.ulibarri@uradenver.com
- James Fagelson, M.D. · Principal investigator
RecruitingChesapeake Urology Research Associates
Towson, Maryland, United States
- Tenia Heigh · Contact443-471-5750theigh@chesuro.com
- Rayna B. Campbell · Contactrbennett@chesuro.com
- Ronald Tutrone, M.D. · Principal investigator
RecruitingSheldon Freedman, MD Ltd.
Las Vegas, Nevada, United States
- Danielle Freedman · Contact702-732-0282 ext. 232dfreedman@freedmanurology.com
- Sheldon Freedman, M.D. · Principal investigator
RecruitingSummit Health
Saddle Brook, New Jersey, United States
- Michelle Mackenzie, RN OCN CCRC · Contact973-436-1755Mmackenzie@summithealth.com
- Glen Gejerman, M.D. · Principal investigator
RecruitingSTART Carolinas
Myrtle Beach, South Carolina, United States
- Matthew Parton · Contact(843) 839-1679matthew.parton@startresearch.com
- Taylor Stephenson · Contact(843) 839-1679taylor.stephenson@startresearch.com
- John Sylvester, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Candel Therapeutics, Inc.
Study ID PrTK05
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.