Biomarker testing 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
This study will test whether giving intraprostatic aglatimagene besadenovec with oral valacyclovir alongside radiation is safe and how the viral material and immune signals behave in men with intermediate‑risk localized prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Candel Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | radiation, prednisone |
| Locations | 7 sites (Peoria, Arizona and 6 other locations) |
| Trial ID | NCT07332000 on ClinicalTrials.gov |
What this trial studies
This is a phase 2a, open-label, multi-center trial enrolling men with intermediate‑risk localized prostate adenocarcinoma to receive intraprostatic injections of aglatimagene besadenovec followed by oral valacyclovir plus standard external beam radiation, with a parallel control arm receiving radiation alone. Approximately 30 participants will receive three courses of the viral vector plus valacyclovir and biospecimen collection, while about 15 control participants will provide matched biospecimens. The study will use validated qPCR assays to measure viral genomes in blood, urine, and semen and will profile immune activation using lymphocyte subsets, cytokines, and circulating tumor-related proteins. Safety and biodistribution (viral shedding) will be monitored continuously at prespecified time points before and after injections.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed intermediate‑risk localized prostate adenocarcinoma who are planning prostate-only EBRT, have ECOG 0–2, and (for the treatment arm) can tolerate transrectal intraprostatic injections and meet basic liver, kidney, and blood count criteria are eligible.
Not a fit: Patients with active liver disease, significant renal impairment, inadequate blood counts, those not planning EBRT, or those unable/unwilling to undergo intraprostatic injections are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enhance tumor cell killing and stimulate an immune response that improves the effectiveness of radiation while defining safety and viral shedding profiles.
How similar studies have performed: Early-phase clinical work with CAN-2409 (aglatimagene besadenovec) and HSV‑tk/prodrug approaches has shown biological activity and immune activation in some settings but has not yet produced definitive, practice‑changing results.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Peoria, Arizona and 6 other locations
- Academic Urology and Urogynecology of Arizona — Peoria, Arizona, United States (Recruiting)
- Colorado Clinical Research — Lakewood, Colorado, United States (Recruiting)
- Urology Associates — Littleton, Colorado, United States (Recruiting)
- Chesapeake Urology Research Associates — Towson, Maryland, United States (Recruiting)
- Sheldon Freedman, MD Ltd. — Las Vegas, Nevada, United States (Recruiting)
- Summit Health — Saddle Brook, New Jersey, United States (Recruiting)
- START Carolinas — Myrtle Beach, South Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.