Actively Recruiting

Phase 1
Phase 2
MALE
NCT01913106

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

Led by The Methodist Hospital Research Institute · Updated on 2016-07-01

25

Participants Needed

1

Research Sites

1122 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-proven local recurrence of prostate cancer without metastatic disease after hormone therapy at least 2 years following completion of definitive radiation therapy
  • Zubrod performance status of 0 to 1
  • White blood cell count at least 4,000/µl and platelets at least 100,000/µl
  • Hemoglobin level at least 8.5 mg/dl
  • Normal partial thromboplastin time and prothrombin time
  • Bilirubin less than 1.5 mg/dl, and AST and alanine aminotransferase less than 2.5 times the upper limit of normal
  • Serum creatinine no greater than 1.6 mg/dl
  • Must undergo pre-treatment evaluation of tumor extent and measurement
  • Nutritional and general physical condition compatible with proposed radiotherapy
  • Not receiving any other experimental 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 entry
  • Prostate volume less than 50 cc
  • PSA greater than 10 ng/ml within the past 3 months may enter study
Not Eligible

You will not qualify if you...

  • Symptomatic metastatic disease
  • Life expectancy less than 10 years
  • Use of corticosteroids or any immunosuppressive drugs
  • HIV positive patients
  • Acute infections requiring therapy (viral, bacterial, or fungal)
  • Cirrhosis
  • Collagen vascular diseases
  • International Prostate Symptom Score (IPSS) greater than 15
  • Prostate volume greater than 50 cc
  • Second active cancer except cutaneous cancer
  • History of allergies to valacyclovir or acyclovir or inability to take oral pills

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Houston Methodist

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Brent Bell, PA-C

CONTACT

B

Brian Butler, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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