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Neoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators.


- candidate number1214
- NTR NumberNTR129
- ISRCTNISRCTN21565532
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsA300009 
- Public TitleNeoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators.
- Scientific TitleNeoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators.
- ACRONYMGenetherapy 1
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. Man, 35-70 years old;
2. Histologically proven adenocarcinoma of the prostate which is clinically localized (including bone scan, not CT);
3. PSA > 4 ng/ml;
4. Medically fit;
5. Scheduled to undergo radical prostatectomy;
6. Neutrophils 2 x 109 /L , platelets 100 x 109 /L, bilirubin < 40 ng/l, ASAT, ASAT < 4 x normal, Hb 6.5 mmol/l, Creatinin < 150 ng/l, normal thromboplastin time (PTT) and prothrombin time (PT);
7. Living within one hour travel distance of the hospital;
8. Written consent for gene therapy after appropriate information.
- Exclusion criteria1. Prior androgen ablation hormonal therapy (except treatment with finasteride If discontinued > 3 months prior to inclusion);
2. Prior surgery or other invasive treatment for BPH (i.e. TURp, hyperthermia, laser prostatectomy, etc);
3. Patients on corticosteroids;
4. Concurrent treatment with immunosuppessive drugs (Imuran, cyclophosphamide etc);
5. Uncontrolled infections (defined as viral, bacterial of fungal infections requiring specific therapy);
6. HIV positive patients;
7. Immunocompromised patients.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-feb-2001
- planned closingdate1-sep-2007
- Target number of participants12
- InterventionsIntratumoral gene therapy with adenoviral vector coding for HSV-tk followed by Ganciclovir treatment.
Patients are treated with gene therapy three weeks prior to radical prostatectomy.
- Primary outcomeTo study the safety and toxicity of adenovirus-mediated thymidine kinase gene therapy for the neoadjuvant treatment of prostate cancer. This is established by patient monitoring from day 0 to day 14, during hospitalization for surgery (day 21 till 28), and subsequently during routine follow-up at weeks 6 and 12, months 6, 9 and 12 and every 6 months thereafter. For this purpose, PSA, blood count, serum hepatic enzumes and creatinine measurements are performed according to routine clinical procedures. A clinical follow-up of one year will be used for safety and toxicity analysis.
- Secondary outcomeTo study and characterize the biological effects of and the immune response induced by adenovirus-mediated thymidine kinase gene therapy.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.H. Bangma
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C.H. Bangma
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center Revolving Fund
- Publications1. van der Linden RRM, Haagmans BL, Mongiat-Artus P, van Doornum GJ, Kraaij R, Kadmon D, Aguilar-Cordova E, Osterhaus ADME, van der Kwast TH and Bangma CH. Virus specific immune responses after human neoadjuvant adenovirus-mediated suicide gene therapy for prostate cancer. European Urology 2005;48:153-61.
- Brief summaryThis Phase I dose-escalating study is designed to analyse the safety and effects of adenovirus-mediated thymidine kinase gene transfection into prostate cells, followed by systemic Ganciclovir treatment in patients with poor risk confined prostate carcinoma. Three weeks after gene therapt radical prostatectomy will be performed, enabling the evaluation of the histological effects.
- Main changes (audit trail)
- RECORD16-aug-2005 - 5-jan-2010


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