N/A
Bron
Verkorte titel
Aandoening
Localised prostate cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
To 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.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
N/A
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Intratumoral 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.
Publiek
P.O. Box 2040
C.H. Bangma
Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4633607
h.j.vanalphen@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040
C.H. Bangma
Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4633607
h.j.vanalphen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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 ³ 2 x 109 /L , platelets ³ 100 x 109 /L, bilirubin < 40 ng/l, ASAT, ASAT < 4 x normal, Hb ³ 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL98 |
NTR-old | NTR129 |
Ander register | : A300009 |
ISRCTN | ISRCTN21565532 |