Status:
ACTIVE_NOT_RECRUITING
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
Lead Sponsor:
Candel Therapeutics, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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. ProstAt...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
711 Patients enrolled
Trial Details
Trial ID
NCT01436968
Start Date
September 1 2011
End Date
December 1 2030
Last Update
July 30 2025
Active Locations (73)
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1
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States, 85297
2
Arizona Urology Specialists
Glendale, Arizona, United States, 85308
3
Arizona Oncology Services Foundation
Multiple Locations, Arizona, United States, 85260
4
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States, 85381