Phase
Condition
Prostate Cancer
Urologic Cancer
Prostate Cancer, Early, Recurrent
Treatment
aglatimagene besadenovec + valacyclovir
External Beam Radiation Therapy (EBRT)
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must give study-specific informed consent prior to enrollment
Histologically confirmed adenocarcinoma of the prostate
Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-riskcriteria
Participants must be planning and medically able to undergo standard or moderatehypofractionated prostate-only EBRT (treatment and control group) and able totolerate 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
Exclusion
Exclusion Criteria:
Active liver disease, including known cirrhosis or active hepatitis
Participants on systemic corticosteroids (> 10 mg prednisone per day) or otherimmunosuppressive 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 opinionof the Investigator, would interfere with treatment or follow-up. For example,participants with diseases that preclude radiation therapy to the prostate such assevere 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 multipleintra-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 (treatmentgroup only)
Study Design
Study Description
Connect with a study center
Academic Urology and Urogynecology of Arizona
Peoria, Arizona 85381
United StatesActive - Recruiting
Colorado Clinical Research
Lakewood, Colorado 80228
United StatesActive - Recruiting
Urology Associates
Littleton, Colorado 80122
United StatesActive - Recruiting
Chesapeake Urology Research Associates
Towson, Maryland 21204
United StatesActive - Recruiting
Chesapeake Urology Research Associates
Towson 4371582, Maryland 4361885 21204
United StatesSite Not Available
Sheldon Freedman, MD Ltd.
Las Vegas, Nevada 89144
United StatesActive - Recruiting
Sheldon Freedman, MD Ltd.
Las Vegas 5506956, Nevada 5509151 89144
United StatesSite Not Available
Summit Health
Saddle Brook, New Jersey 07663
United StatesActive - Recruiting
Summit Health
Saddle Brook 5103637, New Jersey 5101760 07663
United StatesSite Not Available
START Carolinas
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting

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