Neoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators
| ISRCTN | ISRCTN21565532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21565532 |
| Protocol serial number | A300009 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funder | Erasmus Medical Centre (The Netherlands) - Revolving Fund |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 17/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof C.H. Bangma
Scientific
Scientific
Dept. Urology
Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4633607 |
|---|---|
| h.j.vanalphen@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I, non-randomised, non-controlled, dose-escalating study |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | Genetherapy 1 |
| Study objectives | 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 therapy, radical prostatectomy will be performed, enabling the evaluation of the histological effects. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Prostate cancer |
| 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. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | HSV-tk gene transduction, Ganciclovir |
| Primary outcome measure(s) |
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 hospitalisation for surgery (day 21 - 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. |
| Key secondary outcome measure(s) |
To study and characterize the biological effects of and the immune response induced by adenovirus-mediated thymidine kinase gene therapy. |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 12 |
| Key inclusion criteria | 1. Men, 35 - 70 years old 2. Histologically proven adenocarcinoma of the prostate which is clinically localised (including bone scan, not Computed Tomography [CT]) 3. Prostate Specific Antigen (PSA) greater than 4 ng/ml 4. Medically fit 5. Scheduled to undergo radical prostatectomy 6. Neutrophils = 2 x 10^9/l, platelets = 100 x 10^9/l, bilirubin less than 40 ng/l, Aspartate Aminotransferase (ASAT) less than 4 x normal, Haemoglobin (Hb) = 6.5 mmol/l, Creatinine less than 150 ng/l, Partial 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 |
| Key exclusion criteria | 1. Prior androgen ablation hormonal therapy (except treatment with finasteride if discontinued greater than 3 months prior to inclusion) 2. Prior surgery or other invasive treatment for Benign Prostatic Hyperplasia (BPH) (i.e. Transurethral Resection of the Prostate [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. Human Immunodeficiency Virus (HIV) positive patients 7. Immunocompromised patients |
| Date of first enrolment | 20/02/2001 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dept. Urology
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2005 | Yes | No |
