NCT01913106 · The Methodist Hospital Research Institute
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
What this study is about
The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.
View original scientific description
The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- biopsy-proven local recurrence of prostate cancer without metastatic disease after the hormone therapy at least 2 year after the completion of definitive radiation therapy
- Zubrod performance status 0-1
- WBC ≥ 4,000/μl, platelets ≥ 100,000/μl
- hemoglobin ≥ 8.5 mg/dl
- normal partial thromboplastin time and prothrombin time
- bilirubin \< 1.5 mg/dl, and AST and alanine aminotransferase \< 2.5 times the upper limit of normal
- Serum creatinine ≤ 1.6 mg/dl
- Must undergo pre-treatment evaluation of tumor extent and tumor measurement
- Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment
- Not on any other experimental therapeutic cancer treatment
- No active untreated infection
- No major medical or psychiatric illness
- International Prostate Symptom Score (IPSS) less than 15
- Signed study-specific consent form prior to study entry
- Prostate volume less than 50 cc
- PSA \> 10ng/ml within the past 3 months may enter study
Exclusion criteria
- Symptomatic metastasis disease
- Patients with a life expectancy \< 10 years
- Patients on corticosteroids or any immunosuppressive drugs.
- HIV + patients
- Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)
- Patients with cirrhosis.
- Patients with collagen vascular diseases
- International Prostate Symptom Score (IPSS) greater than 15
- Prostate volume greater than 50 cc
- Second active cancer except cutaneous cancer
- Patients with history of allergies to valacyclovir, acyclovier or who cannot take oral pills
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2016 · Source of record for eligibility and locations