New gene therapy injection aims to boost prostate cancer radiation results
NCT ID NCT07332000
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests a gene therapy called aglatimagene besadenovec, given with valacyclovir, in 45 men with intermediate-risk prostate cancer who will also receive radiation. The main goal is to see how the therapy spreads in the body and to measure immune responses and tumor markers like PSA. Participants must be planning radiation and able to tolerate prostate injections.
Why investors are watching
Candel Therapeutics runs this Phase 2a study of aglatimagene besadenovec plus valacyclovir in 45 men with localized, intermediate-risk prostate cancer who plan to receive external beam radiation therapy. The trial measures biomarkers and how the drug spreads in the body, so it tests whether the treatment does what the company intends before anyone runs a larger study. For a micro-cap company, this readout can shape how the company's pipeline is judged.
If it works: A positive biomarker and biodistribution result may support moving the program into later-stage testing and could draw partner or investor interest. It may also strengthen the case for the company's gene therapy approach in prostate cancer.
If it fails: If the biomarkers do not move as hoped, or the trial is delayed, the program could stall and the company may need to rethink or fund more work before advancing. Early-phase trials often fail, and a small company has few other shots.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Academic Urology and Urogynecology of Arizona
RECRUITINGPeoria, Arizona, 85381, United States
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Chesapeake Urology Research Associates
RECRUITINGTowson, Maryland, 21204, United States
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Colorado Clinical Research
RECRUITINGLakewood, Colorado, 80228, United States
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START Carolinas
RECRUITINGMyrtle Beach, South Carolina, 29572, United States
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Sheldon Freedman, MD Ltd.
RECRUITINGLas Vegas, Nevada, 89144, United States
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Summit Health
RECRUITINGSaddle Brook, New Jersey, 07663, United States
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Urology Associates
RECRUITINGLittleton, Colorado, 80122, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Prostate tumors hide a Nerve-Fueled neighborhood, and scientists are mapping it
- A proactive care plan may help men with prostate cancer live better
- Can a simple blood test outsmart prostate cancer?
- A sharper eye on prostate cancer: could new imaging spare healthy tissue?
- Can a new drug combo tame resistant prostate cancer?