No registrations found.
ID
Source
Brief title
Health condition
Localised prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
To study and characterize the biological effects of and the immune response induced by adenovirus-mediated thymidine kinase gene therapy.
Background summary
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.
Study objective
N/A
Study design
N/A
Intervention
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.
P.O. Box 2040
C.H. Bangma
Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4633607
h.j.vanalphen@erasmusmc.nl
P.O. Box 2040
C.H. Bangma
Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4633607
h.j.vanalphen@erasmusmc.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL98 |
| NTR-old | NTR129 |
| Other | : A300009 |
| ISRCTN | ISRCTN21565532 |