NCT01913106CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 25 Jul 2013
- Start date
- Jun 2007
- Primary completion date
- Dec 2016
- Lead sponsor
- The Methodist Hospital Research Institute
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT01913106
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 4
- From Jun 2007 to the primary completion date, Dec 2016
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on corticosteroids or any immunosuppressive drugs.
Other illness
- Symptomatic metastasis disease
- HIV + patients
- Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)
- Patients with collagen vascular diseases
- Second active cancer except cutaneous cancer
- Patients with history of allergies to valacyclovir, acyclovier or who cannot take oral pills
Age
- Patients with a life expectancy \< 10 years
Other
- Patients with cirrhosis.
- International Prostate Symptom Score (IPSS) greater than 15
- Prostate volume greater than 50 cc
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.