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Hormone Therapy

Valacyclovir for Prostate Cancer

Phase 2
Waitlist Available
Led By E. Brian Butler, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-year post treatment
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines gene therapy with existing treatments.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-year post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-year post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biochemical control rate
Secondary outcome measures
Overall survival rate
Pathologic complete response rate
Safety based on questionnaire and clinical adverse event monitoring

Side effects data

From 2011 Phase 3 trial • 91 Patients • NCT00031486
40%
Nausea
30%
Headache
18%
Urinary tract infection
18%
Depression
15%
Fatigue
13%
Insomnia
13%
Anxiety
10%
Constipation
10%
Vomiting
10%
Dyspepsia
10%
Weight decreased
10%
Hypoaesthesia
8%
Chest pain
8%
Tremor
8%
Blood creatinine increased
8%
Syncope
8%
Pyrexia
5%
Paraesthesia
5%
Ageusia
5%
Dysgeusia
5%
Hallucinaion
5%
Irritability
5%
White blood cells urine positive
5%
Reticulocyte count abnormal
5%
Parosmia
5%
Back pain
5%
Dizziness
5%
Encephalitis herpes
5%
Muscular weakness
5%
Convulsion
5%
Alanine aminotransferase increased
5%
Arthralgia
5%
Candidiasis
5%
Hyperreflexia
3%
Nightmares
3%
Salivary hypersecretion
3%
Stress
3%
Papillary thyroid cancer
3%
Retinal ischaemia
3%
Loss of consciousness
3%
Panic attack
3%
Brain abscess
3%
Cerebrovascular accident
3%
Agitated depression
3%
Amnesia
3%
Asthenia
3%
Gingival hyperplasia
3%
Blood glucose increased
3%
Billiary dyskinesia
3%
Pulmonary embolism
3%
Agitation
3%
Blood urea
3%
Blood uric acid abnormal
3%
Diverticulitis
3%
Blood uric acid decreased
3%
Haemoglobin decreased
3%
Meralgia paraesthetica
3%
Cerebral infarction
3%
Dysaesthesia
3%
Nervousness
3%
Weight increased
3%
Coagulopathy
3%
Neck pain
3%
Creatinine renal clearance decreased
3%
Renal failure acute
3%
Confusional state
3%
Depressed level of consciousness
3%
Herpes zoster
3%
Neutrophil count abnormal
3%
Urosepsis
3%
Oedema peripheral
3%
Urine analysis abnormal
3%
Osteoarthritis
3%
Abdominal pain
3%
Pharyngitis
3%
Vulvovaginal mycotic infection
3%
Suicide attempt
3%
Aphthous stomatitis
3%
Diarrhoea
3%
Dysphagia
3%
Embolism
3%
Encephalitis
3%
Fall
3%
Wound infection
3%
Abdominal discomfort
3%
Abdominal distension
3%
Abdominal pain upper
3%
Blood alkaline phosphatase increased
3%
Blood creatinine abnormal
3%
Blood glucose abnormal
3%
Eosinophil count abnormal
3%
Feeling cold
3%
Gingivitis
3%
Global anmesia
3%
Haematocrit abnormal
3%
Haemoglobin abnormal
3%
Haemorrhage intracranial
3%
Musculoskeletal discomfort
3%
Musculoskeletal disorder
3%
Pharyngitis streptococcal
3%
Sialoadenitis
3%
Tooth loss
3%
Upper respiratory tract infection
3%
Dry mouth
3%
Alanine aminotransferase abnormal
3%
Anosmia
3%
Migraine
3%
Nystagmus
3%
Radial nerve palsy
3%
Red blood cell count abnormal
3%
Lymphadenectomy
3%
Hyperaesthesia
3%
Hypertonia
3%
Hypomania
3%
Influenza
3%
Obsessive-compulsive disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valacyclovir
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gene Therapy, ADT, RT, and SurgeryExperimental Treatment6 Interventions
The investigational gene therapy, ADV/HSV-tk, will be administered by injection into the prostate at 5 x 10[11] virus particles (1.25 x 10[11] virus particles per tumor quadrant in 4 quadrants) on day 0 and day 30. The recommended dose of Valacyclovir for this trial is 2 g orally t.i.d. for 14 days (day 1 to day 15 and days 31 to 45). The recommended dose for Bicalutamide therapy in combination with an LHRH analogue is one 50 mg tablet once daily (morning or evening). Leuprolide acetate 7.5mg depot injection will be injected monthly for a total of 2 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valaciclovir
FDA approved
Bicalutamide
FDA approved
Leuprolide
FDA approved
Radical prostatectomy
2016
Completed Phase 3
~1700

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,315 Total Patients Enrolled
1 Trials studying Prostate Cancer
80 Patients Enrolled for Prostate Cancer
E. Brian Butler, MD3.04 ReviewsPrincipal Investigator - The Methodist Hospital Research Institute
The Methodist Hospital Research Institute
5Patient Review
Dr. Butler was able to see me quickly after a referral phone call which was greatly appreciated. He was very knowledgeable about my aggressive prostate cancer and offered several treatment options. I chose to participate in one of his studies and I am very happy with the results. His staff is also excellent.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Valacyclovir have a history of being studied in other research?

"At the moment, there are a total of 108 studies being conducted that involve valacyclovir. Out of those, 34 have reached Phase 3 testing. Most of these trials are based in Duarte, California; however, this treatment is being tested in 7167 different locations globally."

Answered by AI

What are the common treatments associated with Valacyclovir?

"While most often used to treat human immunodeficiency virus type 1 (hiv-1) infection, Valacyclovir has also been found to ameliorate conditions like chickenpox, anemia, and stage d2 prostatic carcinoma."

Answered by AI

Have there been other studies like this one in the past?

"AstraZeneca's Valacyclovir has undergone 265 clinical trials since the year 2000. Of these, 108 are still active and being conducted across 1425 cities in 49 countries. The first study was a Phase 3 drug approval stage trial that involved 600 participants."

Answered by AI

Are there any dangers associated with taking Valacyclovir?

"Valacyclovir falls into Phase 2 of clinical trials, meaning that while there is evidence supporting its safety, there is currently no data to suggest that the medication is effective."

Answered by AI

How many people have been signed up to participate in this research?

"That is correct. The information available on clinicaltrials.gov shows that this trial is still recruiting patients. This particular study was initially posted on 8/2/2018 and has been edited as recently as 4/5/2021. There is space for 60 people at 1 site."

Answered by AI

Are there any unfilled positions in this trial for new patients?

"Yes, this information can be found on clinicaltrials.gov. The trial was posted on 8/2/2018 and was edited on 4/5/2021, which suggests that they are still actively recruiting patients."

Answered by AI
Recent research and studies
International Journal of CancerJournal
Estimates of Worldwide Burden of Cancer in 2008: GLOBOCAN 2008
Ferlay, Jacques, Hai-Rim Shin, Freddie Bray, David Forman, Colin Mathers, and Donald Maxwell Parkin. 2010. “Estimates of Worldwide Burden of Cancer in 2008: GLOBOCAN 2008”. International Journal of Cancer. Wiley. doi:10.1002/ijc.25516.
Annual Review of ImmunologyJournal
Immunogenic Cell Death in Cancer Therapy
Kroemer, Guido, Lorenzo Galluzzi, Oliver Kepp, and Laurence Zitvogel. 2013. “Immunogenic Cell Death in Cancer Therapy”. Annual Review of Immunology. Annual Reviews. doi:10.1146/annurev-immunol-032712-100008.
International Journal of Radiation Oncology*Biology*PhysicsJournal
Dose Escalation and Quality of Life in Patients with Localized Prostate Cancer Treated with Radiotherapy: Long-term Results of the Dutch Randomized Dose-escalation Trial (CKTO 96-10 Trial)
Al-Mamgani, Abrahim, Wim L.J. van Putten, Gerard J. van der Wielen, Peter C. Levendag, and Luca Incrocci. 2011. “Dose Escalation and Quality of Life in Patients with Localized Prostate Cancer Treated with Radiotherapy: Long-term Results of the Dutch Randomized Dose-escalation Trial (CKTO 96-10 Trial)”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2009.12.039.
International Journal of Radiation Oncology*Biology*PhysicsJournal
Phase I–II Trial Evaluating Combined Intensity-modulated Radiotherapy and in Situ Gene Therapy with or Without Hormonal Therapy in Treatment of Prostate Cancer—interim Report on PSA Response and Biopsy Data
Teh, Bin S, Gustavo Ayala, Laura Aguilar, Wei-Yuan Mai, Terry L Timme, Maria T Vlachaki, Brian Miles, et al.. 2004. “Phase I–II Trial Evaluating Combined Intensity-modulated Radiotherapy and in Situ Gene Therapy with or Without Hormonal Therapy in Treatment of Prostate Cancer—interim Report on PSA Response and Biopsy Data”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2003.09.083.
~9 spots leftby Apr 2025
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