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RecruitingPhase 2

A Biomarker Study 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Approximately 30 patients with intermediate risk prostate cancer will be recruited to the treatment arm and receive 3 courses of aglatimigene besadenovec by intraprostatic injection followed by orally administered valacyclovir."
  • "EBRT will start following the second injection."
  • "Biospecimens (blood, urine, semen) will be collected at specifed timepoints before and after each injection to assess biodistribution and immune response."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests aglatimagene besadenovec plus valacyclovir in men with prostate cancer that has not spread and is at medium risk. It looks at signs in the body called biomarkers and where the study treatment goes in the body. It is for men who plan to have radiation aimed at the prostate from outside the body.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and give informed consent to join the study.
  • Have prostate adenocarcinoma, a type of cancer, confirmed by a tissue test.
  • Have prostate cancer that meets national guidelines for medium risk.
  • Plan to have, and be medically able to receive, one of the allowed radiation schedules aimed only at the prostate.
  • Be able to care for yourself and be up and about at least half of waking hours, even if you cannot work.
  • For the treatment group: be able to receive several injections into the prostate, guided by an ultrasound probe in the rectum.
  • For the treatment group: have a liver blood test called AST below 3 times the upper normal limit, creatinine below 2 mg/dL, and kidney filtering above 30 mL/min.
  • For the treatment group: have white blood cells above 3,000/mm3 and platelets, which help blood clot, above 100,000/mm3.

Who can't join

  • Have active liver disease, including known liver scarring called cirrhosis or active hepatitis.
  • Take steroid medicines at more than 10 mg of prednisone per day, or other medicines that weaken the immune system; or have known HIV.
  • Have cancer in nearby lymph nodes or distant parts of the body, or plan to have radiation to the whole pelvis.
  • Have another current cancer, except squamous cell or basal cell skin cancer.
  • Have another serious illness or poor organ function that the study doctor thinks would prevent treatment or follow-up. Examples include severe prostate swelling or inflammatory bowel disease that prevents prostate radiation.
  • Have had prostate cancer treatment before, except TURP, a procedure that removes prostate tissue through the urine tube. After TURP, the study doctor must decide that prostate injections are still possible.
  • Have had or plan to have surgery to remove the testicles to lower hormone levels.
  • For the treatment group: have a known sensitivity or allergy to acyclovir or valacyclovir.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (7)

AZ

CO

MD

NJ

NV

SC