Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Candel Therapeutics, Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed adenocarcinoma of the prostate
Patients choosing active surveillance
Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
* NCCN Low Risk is defined as having all of the following: PSA \< 10 ng/ml, Gleason ≤ 6, T1-T2a
* NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
* High Risk with a single high risk feature is defined as having only one of the following: PSA\>20 ng/ml, Gleason score 8-10, or T3a
* Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
ECOG Performance status 0-2
You may not be if
Active liver disease, including known cirrhosis or active hepatitis
Patients on systemic corticosteroids (\>10 mg prednisone per day) or other immunosuppressive drugs
Known HIV+ patients
Regional lymph node involvement or distant metastases
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
Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
