Back to search results

HSV-tk + Valacyclovir with Brachytherapy for Recurrent Prostate Cancer

This study is testing a new approach for men with prostate cancer that has come back after radiation therapy and has not spread to other parts of the body. It combines a gene therapy called HSV-tk + Valacyclovir with brachytherapy (a type of radiation therapy where radioactive seeds are placed inside the body). The HSV-tk gene, from a herpes simplex virus, is inserted into prostate tumor cells. This gene helps turn valacyclovir into a substance that can kill cancer cells. The main goal is to see how safe this combination treatment is and to measure the 5-year biochemical disease-free survival rate (how many men are free of cancer based on blood tests after 5 years). You might be able to join if you have recurrent prostate cancer, good general health, and specific blood test results.

Study design
This is a Phase I-II interventional study, meaning it's an early-stage trial looking at safety and effectiveness. It plans to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures outcomes at a 5-year biochemical disease-free survival rate, suggesting a follow-up period of at least 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01913106

HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer

Recruiting
PHASE1All AgesInterventionalTreatment
The Methodist Hospital Research Institute
~25 participants
Updated 2016-07-01 on ClinicalTrials.gov
What's tested:HSV-tk +Valacyclovir in Combination with Brachytherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1. Safety based on standard laboratory and clinical adverse event monitoring
Measured over 5-year biochemical disease free survival rate

Conditions

Prostatic Neoplasms

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Edward B Butler, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Brent Bell, PA-C
[email protected]
713-394-1105
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • 1. Safety based on standard laboratory and clinical adverse event monitoring5-year biochemical disease free survival rate