Gene therapy plus hormone therapy, radiotherapy, and surgery for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective phase II study evaluating the combination of HSV-tk+ valacyclovir gene therapy with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and planned prostatectomy in men with previously untreated high-risk prostate cancer. The study will measure efficacy through PSA changes, physical exams, re-biopsy and prostatectomy tissue analyses, and assessments of immune and histological responses. Safety will be tracked using CTCAE and RTOG neuro-toxicity criteria, along with standard lab tests and organ function monitoring. Participants will be followed for PSA nadir, PSA progression-free survival, local and distant progression, and overall survival. Eligibility requires biopsy-proven adenocarcinoma with high-risk features, no prior prostate treatment, good performance status, and adequate organ function, among other criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All patients must have biopsy proven adenocarcinoma of the prostate
* Patients in should have at least one or more of the following characteristics PSA\>20, Gleason score 8-10, Primary Gleason pattern 5, \>4 cores with Gleason 8-10, and Clinical stage T3a-T4.
* No prior surgical, hormonal, or radiotherapy prostate treatment.
* ECOG performance status 0-1
* No evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers.
* Patients must have PSA within 3 months of entry.
* Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his/her designee) with the aid of written information.
* Willing to provide biopsies as required by the study.
* Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol:
* serum creatinine \< 1.5 mg%
* T. bilirubin \< 2.5 mg%, ALT and AST \< 2x normal
* Pts \> 100,000/mm3 , ANC\> 1500 mm , Hgb\> 10gm%
* Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)

Exclusion Criteria:

* Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months.
* Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start.
* Evidence of metastatic disease
* Prostate volume \>50cc
* Prior prostate surgery (hyperthermia, cryotherapy, etc.)
* Prior pelvic radiotherapy
* Prior androgen ablation hormonal therapy (except finasteride if discontinued \> 3 mo. prior to enrollment)
* Patients on corticosteroids or any immunosuppressive drugs.
* History of liver disease, such as cirrhosis or active/chronic hepatitis B or C.
* History of or current alcohol misuse/abuse within the past 12 months.
* Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector/Valacyclovir).
* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).
* No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 5 years.
* Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.
* Patients \< 18 years of age
* Unwilling or unable to comply with the study protocol.

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: E. Brian Butler, MD — The Methodist Hospital Research Institute
• Study coordinator: Emily Hsiao, Ph.D.
• Email: khsiao@houstonmethodist.org
• Phone: 713-383-5115

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.