Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New gene therapy injection aims to boost prostate cancer radiation results

NCT ID NCT07332000

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Localized intermediate-risk prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Academic Urology and Urogynecology of Arizona

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Chesapeake Urology Research Associates

    RECRUITING

    Towson, Maryland, 21204, United States

  • Colorado Clinical Research

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • START Carolinas

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Sheldon Freedman, MD Ltd.

    RECRUITING

    Las Vegas, Nevada, 89144, United States

  • Summit Health

    RECRUITING

    Saddle Brook, New Jersey, 07663, United States

  • Urology Associates

    RECRUITING

    Littleton, Colorado, 80122, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.