Prostate Cancer Clinical Trial
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
The purpose of this study is to evaluate the effectiveness of ProstAtakÂ® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtakÂ® involves the use of aglatimagene besadenovec (CAN-2409) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtakÂ® has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtakÂ® or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
Inclusion Criteria include:
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 â‰¤ 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
Exclusion Criteria include:
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
Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
Patients who had or plan to use ADT or have history of an orchiectomy.
Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
Known sensitivity or allergic reactions to acyclovir or valacyclovir
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There are 22 Locations for this study
Golden Colorado, 80401, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
New Orleans Louisiana, 70119, United States
Bethesda Maryland, 20889, United States
Kansas City Missouri, 64128, United States
Reno Nevada, 89502, United States
Hackensack New Jersey, 07601, United States
North Hills New York, 11042, United States
Syracuse New York, 13210, United States
Middleburg Heights Ohio, 44130, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Springfield Oregon, 97477, United States
Lancaster Pennsylvania, 17604, United States
Pittsburgh Pennsylvania, 15212, United States
Charleston South Carolina, 29401, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77384, United States
Tomball Texas, 77375, United States
Richmond Virginia, 23249, United States
Salem Virginia, 24153, United States
Mexico City , , Mexico
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