No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
45 (estimated)
Sponsor
Candel Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for men with localized, intermediate-risk prostate cancer who are planning to receive radiation therapy. Participants will receive injections of a treatment along with a medication and will be monitored throughout the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years of age or older.
I have been diagnosed with prostate cancer.
I meet the National Comprehensive Cancer Network's intermediate-risk criteria.
I am planning to receive radiation therapy and can tolerate multiple injections.
I have a performance status of 0-2.
I have been informed and consented to participate.
My lab tests meet specific criteria.
You may not be able to join if
I have active liver disease.
I am taking more than 10 mg of prednisone or other immunosuppressive drugs.
I am known to be HIV positive.
I have regional lymph node involvement or distant metastases.
I have another type of cancer except for certain skin cancers.
I have other serious health issues that could interfere with the study.
I have had treatment for prostate cancer, except for a specific surgery.
I am planning to have orchiectomy as a hormonal treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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)
Contacts
No contact information available.
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.