Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy in previously untreated high-risk prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Acyclovir; Androgens; Bicalutamide; Leuprolide; Valacyclovir

Criteria

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.