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New treatment option for Prostate Cancer Patients Treated by Radiotherapy
Official title A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
ClinicalTrials.gov ID: NCT07332000
What this study is testing
What is aglatimagene besadenovec + valacyclovir?
aglatimagene besadenovec + valacyclovir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prostate cancer patients treated by radiotherapy.
Also referred to as CAN-2409 plus prodrug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Participants must give study-specific informed consent prior to enrollment
- Histologically confirmed adenocarcinoma of the prostate
- Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
- Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group)...
- 18 years of age or older
You likely can't join if
- Active liver disease, including known cirrhosis or active hepatitis
- Participants on systemic corticosteroids (\> 10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ participants
- Regional lymph node involvement or distant metastases
- Participants planning to receive whole pelvic irradiation
- Other current malignancy (except squamous or basal cell skin cancers)
See the full eligibility criteria
- Participants must give study-specific informed consent prior to enrollment
- Histologically confirmed adenocarcinoma of the prostate
- Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
- 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...
- 18 years of age or older
- Performance status must be Eastern Cooperative Oncology Group 0-2
- The following laboratory criteria must be met (treatment group only):
- Aspartate aminotransferase (AST) \< 3 x upper limit of normal
- Serum creatinine \< 2 mg/dL
- Calculated creatinine clearance \> 30 mL/min
- White blood cells \> 3000/mm3
- Platelets \>100,000/mm3
- Active liver disease, including known cirrhosis or active hepatitis
- Participants on systemic corticosteroids (\> 10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ participants
- Regional lymph node involvement or distant metastases
- Participants planning to receive whole pelvic irradiation
- Other current malignancy (except squamous or basal cell skin cancers)
- 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...
- 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.
- Participants who had or plan to have orchiectomy as the form of hormonal ablation
- Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Arizona, United States
- Lakewood, Colorado, United States
- Littleton, Colorado, United States
- Towson, Maryland, United States
- Las Vegas, Nevada, United States
- Saddle Brook, New Jersey, United States
- Myrtle Beach, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Arizona, United States; Lakewood, Colorado, United States; Littleton, Colorado, United States; Towson, Maryland, United States; Las Vegas, Nevada, United States; Saddle Brook, New Jersey, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.