NCT07332000 A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
| NCT ID | NCT07332000 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Candel Therapeutics, Inc. |
| Condition | Prostate Cancer Patients Treated by Radiotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2025-10-30 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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)
Frequently Asked Questions
Who can join the NCT07332000 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Patients Treated by Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07332000 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07332000 currently recruiting?
Yes, NCT07332000 is actively recruiting participants. Visit ClinicalTrials.gov or contact Candel Therapeutics, Inc. to inquire about joining.
Where is the NCT07332000 trial being conducted?
This trial is being conducted at Peoria, United States, Lakewood, United States, Littleton, United States, Towson, United States and 3 additional locations.
Who is sponsoring the NCT07332000 clinical trial?
NCT07332000 is sponsored by Candel Therapeutics, Inc.. The trial plans to enroll 45 participants.
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