Phase 2 Prostate Cancer Trial, Recruiting NCT01913106 Sponsor: The Methodist Hospital Research Institute Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT01913106
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your prostate cancer has come back locally (confirmed by biopsy) without spreading to other parts of the body, after you previously received hormone therapy and radiation treatment that finished at least 2 years ago
  • You are generally active and able to carry out daily activities with little or no restriction (confirm with trial site)
  • Your blood cell counts are at acceptable levels — enough white blood cells and platelets (confirm with trial site)
  • Your hemoglobin (a measure of red blood cells) is at an acceptable level (confirm with trial site)
  • Your blood clotting tests are within normal range (confirm with trial site)
  • Your liver function test results are within acceptable limits (confirm with trial site)
  • Your kidney function is within an acceptable range (confirm with trial site)
  • You have had tests done to measure the size and extent of your tumor before starting treatment
  • Your overall health and nutrition are considered suitable for radiation treatment
  • You are not currently taking part in any other experimental cancer treatment
  • You do not have any active, untreated infections
  • You do not have any serious medical or mental health conditions
  • Your urinary symptom score (a standard questionnaire about prostate-related urinary problems) is below 15
  • You have signed the study consent form before joining
  • Your prostate is smaller than 50 cc in size
  • Your PSA level (a prostate-related blood marker) was above 10 ng/ml within the past 3 months

Who may not be able to join:

  • Your cancer has spread to other parts of the body and is causing symptoms
  • Your life expectancy is estimated to be less than 10 years
  • You are currently taking corticosteroids or any medicines that suppress the immune system
  • You are HIV positive
  • You have an active infection (viral, bacterial, or fungal) that requires treatment
  • You have cirrhosis (serious scarring of the liver)
  • You have a connective tissue or autoimmune condition affecting blood vessels (collagen vascular disease) (confirm with trial site)
  • Your urinary symptom score is greater than 15
  • Your prostate is larger than 50 cc in size
  • You currently have another active cancer, apart from skin cancer
  • You have had an allergic reaction to valacyclovir or acyclovir, or you are unable to swallow oral pills

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Edward B Butler, MD, The Methodist Hospital Research Institute

Phone: 713-394-1105

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
The Methodist Hospital Research Institute
Registry
ClinicalTrials.gov
Start date
1 June 2007
Est. completion
1 December 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

1. Safety based on standard laboratory and clinical adverse event monitoring

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov