Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof C.H. Bangma

ORCID ID

Contact details

Dept. Urology
Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4633607
h.j.vanalphen@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A300009

Study information

Scientific title

Acronym

Genetherapy 1

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Phase I, non-randomised, non-controlled, dose-escalating study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

HSV-tk gene transduction, Ganciclovir

Primary outcome measures

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.

Secondary outcome measures

To study and characterize the biological effects of and the immune response induced by adenovirus-mediated thymidine kinase gene therapy.

Overall trial start date

20/02/2001

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

12

Participant 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

Recruitment start date

20/02/2001

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dept. Urology
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands) - Revolving Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15967266

Publication citations

  1. Results

    van der Linden RR, Haagmans BL, Mongiat-Artus P, van Doornum GJ, Kraaij R, Kadmon D, Aguilar-Cordova E, Osterhaus AD, van der Kwast TH, Bangma CH, Virus specific immune responses after human neoadjuvant adenovirus-mediated suicide gene therapy for prostate cancer., Eur. Urol., 2005, 48, 1, 153-161, doi: 10.1016/j.eururo.2005.02.013.

Additional files

Editorial Notes