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Brachytherapy

Gene Therapy + Brachytherapy for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Edward B 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

No active untreated infection

Prostate volume less than 50 cc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-year post treatment

Awards & highlights

Study Summary

This trial will test a new gene therapy approach for treating recurrent prostate cancer by combining it with brachytherapy. The goal is to improve control of the cancer and prevent metastasis.

Who is the study for?

Men with biopsy-proven recurrent prostate cancer, no metastasis, and who've had hormone therapy and radiation. They must have a PSA >10ng/ml, good organ function, no major illnesses or second active cancers, not be on immunosuppressants or other experimental treatments, and able to take oral pills.Check my eligibility

What is being tested?

The trial is testing HSV-tk + Valacyclovir gene therapy combined with brachytherapy for men whose prostate cancer has returned. It's in early stages (Phase I - II) to see if it can prevent the spread of cancer or control existing metastasis.See study design

What are the potential side effects?

Potential side effects may include reactions related to gene therapy such as flu-like symptoms, pain at injection site for brachytherapy; valacyclovir could cause headache, nausea; specific side effects will be monitored due to the novel combination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any untreated infections.

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My prostate is smaller than 50 cc.

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I do not have any severe physical or mental health conditions.

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I can carry out all my usual activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-year post treatment

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

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

Secondary outcome measures

Evaluate immunological markers

Local control survival (measured by PSA and biopsy)

Trial Design

1Treatment groups

Experimental Treatment

Group I: HSV-tk + Valacyclovir and BrachytherapyExperimental Treatment1 Intervention

You will be given an antibiotic (Ciproflaxin) to take twice a day beginning the day before the procedure, and continuing for a total of 3 - 5 days. You will also be given 4 pills called (Valtrex) valacyclovir to take three times a day for 14 days, beginning the day before the procedure. You will be given a pill diary in which you will record each dose of valacyclovir that you take. You will receive brachytherapy (radioactive seed placement) the day after you begin taking your pills. After the radioactive seeds are placed, while you are still in the operating room, you will receive an injection into your prostate of 1 or 2 ml (one-fifth or two-fifths of a teaspoon) of a solution of the vector carrying the gene.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

271 Previous Clinical Trials

80,350 Total Patients Enrolled

2 Trials studying Prostate Cancer

140 Patients Enrolled for Prostate Cancer

Edward B Butler, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Media Library

Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01913106 — Phase 1 & 2

Prostate Cancer Research Study Groups: HSV-tk + Valacyclovir and Brachytherapy

Prostate Cancer Clinical Trial 2023: Brachytherapy Highlights & Side Effects. Trial Name: NCT01913106 — Phase 1 & 2

Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01913106 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment a novel approach to the issue?

"Presently, 11 studies related to HSV-tk +Valacyclovir in Combination with Brachytherapy are active across 121 cities and 4 countries. The initial trial of this kind was conducted by Millennium Pharmaceuticals, Inc., in 2006 and involved 46 participants who completed its Phase 2 drug approval stage; over the course of the past 14 years, an additional 64 trials have been held."

Answered by AI

Is enrollment still open for this research study?

"Affirmative. The clinical trial was posted on June 1, 2007 and recently updated on June 29th, 2016 according to the information found on clinicialtrials.gov - this research project is actively searching for 25 individuals from a single medical centre."

Answered by AI

How many individuals are taking part in this medical experiment?

"Affirmative. Clinicaltrials.gov's information indicates that this study, first posted on 6/1/2007, is actively recruiting volunteers. An estimated 25 participants must be enrolled from a single medical centre."

Answered by AI

What research has been undertaken to evaluate the efficacy of a combination approach utilizing HSV-tk and Valacyclovir with Brachytherapy?

"Presently, 11 research initiatives are being conducted that examine the efficacy of HSV-tk + Valacyclovir in Combination with Brachytherapy. Of these trials, one is currently at Phase 3 and 199 different sites are conducting studies related to this topic - primarily located within Houston, Texas."

Answered by AI

What therapeutic objectives are typically pursued with the implementation of HSV-tk +Valacyclovir in Combination with Brachytherapy?

"Genital herpes is usually treated using HSV-tk +Valacyclovir in Combination with Brachytherapy. This same medication regimen can also be utilized to treat other conditions such as HIV, oral herpes, and varicella zoster virus infection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2007. "HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01913106.

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