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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21955

Enrollment

Registered

2005-08-23

Start date

2001-02-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localised prostate cancer

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Contacts

Public ContactC.H. Bangma

Erasmus Medical Center, Department of Urology, P.O. Box 2040

h.j.vanalphen@erasmusmc.nl+31 (0)10 4633607

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)