Oncolytic adenovirus therapy as an adjuvant treatment for localised prostate cancer.

Completed

Conditions: 10036958
prostate cancer
Prostate carcinoma
10038597

Registration Number: NL-OMON43563

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

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
7. Chemistry:
- Aspartate aminotransferase (AST) * 2.5 x ULN
- Alanine aminotransferase (ALT) * 2.5 x ULN
- Creatinin * 1.5 x ULN
- Total bilirubin * 1.5 x ULN
8. Living within one hour travel distance of the hospital
9. Green light from anaesthesist, fit to undergo RP

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is dose-limiting toxicity between 1x10E11 and 5x10E12<br /><br>Virus Particles Ad[I/PPT-E1A], defined as any irreversible grade 3 or 4<br /><br>toxicity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are histopathological changes with respect to<br /><br>necrosis and inflammatory features, immunological changes with respect to the<br /><br>systemic and local innate and adaptive immune system profile, and the presence<br /><br>of tumour-specific and adenovirus-specific T<br /><br>cells in blood and the prostate before, during and after Ad[I/PPT-E1A]<br /><br>oncolytic adenovirus therapy.</p><br>