RightFit
RecruitingPhase 1 / Phase 2

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

Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

TX