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Purpose

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

include: - Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature - NCCN Intermediate Risk is defined as having at least one of the following: 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: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1 - Planning to undergo standard prostate-only external beam radiation therapy - ECOG Performance Status 0-2

Exclusion Criteria

include: - Liver disease, including known cirrhosis or active hepatitis - Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs - Known HIV+ patients - Regional lymph node involvement or distant metastases - Patients planning to receive whole pelvic irradiation - Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months - Patients who had or plan to have orchiectomy as the form of hormonal ablation - Known sensitivity or allergic reactions to acyclovir or valacyclovir

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ProstAtak® 		Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
  • Biological: Aglatimagene besadenovec + valacyclovir
    Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.
    Other names:
    • AdV-tk
    • CAN-2409
Placebo Comparator
Control 		Placebo + valacyclovir + radiation therapy +/- ADT
  • Biological: Placebo + valacyclovir
    Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.

More Details

Status
Active, not recruiting
Sponsor
Candel Therapeutics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.