NL-OMON43563
Completed
Not Applicable
Oncolytic adenovirus therapy as an adjuvant treatment for localised prostate cancer. - Oncolytic adenovirus therapy in PCa
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites18 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1\. Men \* 18 years, scheduled to undergo radical prostatectomy in Erasmus MC
- •2\. Histologically proven adenocarcinoma of the prostate
- •3\. Clinical Stage T1b\-T2, Nx\-N0, M0 disease
- •4\. Life expectancy \> 10 years according to the European Association of Urology guidelines 2009
- •5\. Written informed consent
- •6\. Haematology:
- •\- Absolute neutrophil count ANC \* 1\.5 x 10E9 /L
- •\- Lymphocyte counts \* 0\.8 x 10E9/L
- •\- Platelets \* 100 x 10E9 /L
- •\- Haemoglobin \* 6\.2 mmol/L
Exclusion Criteria
- •1\. Prior androgen ablation hormonal therapy (except treatment with finasteride \- if discontinued \>
- •3 months prior to inclusion in current protocol)
- •2\. Prior prostatic surgical procedure during which tissue was resected, except biopsies.
- •3\. Continuous daily use of oral prednisone, oral dexamethasone, or other systemic corticosteroids for more than 14 days within 3 months prior to screening (inhaled, nasal and local steroids are allowed (e.g. joint injection)
- •4\. Concurrent treatment with immunosuppressive drugs (Imuran, cyclophosphamide, etc.).
- •5\. Patients with uncontrolled infections, including uncontrolled infections of the urinary tract
- •(defined as viral, bacterial or fungal infections requiring specific therapy)
- •6\. Patients known to be HIV\-positive or having another severe immunodeficiency
- •7\. Prostatitis during the past 12 months
- •8\. Any condition which, in the opinion of the investigator, would prevent full and safe participation in this trial, or would interfere with the evaluation of the trial endpoints
Investigators
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