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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

Must not have

Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)

Prostate volume greater than 50 cc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any current infections needing treatment.

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My prostate is larger than 50 cc.

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I am currently taking corticosteroids or immunosuppressive drugs.

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I have cirrhosis.

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I am allergic to valacyclovir or acyclovir, or I cannot take pills.

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I have another active cancer besides skin cancer.

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My cancer has spread and is causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met