RightFit
RecruitingPhase 2

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

Phase II Study Evaluating HSV-tk + Valacyclovir Gene Therapy in Combination With Androgen Deprivation Therapy, Brachytherapy, External Beam Radiotherapy, and Prostatectomy for High-Risk Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Clinical response as evaluated by changes in serum PSA level and digital rectal examination as well as by histological alterations on re-biopsy and prostatectomy such as the presence of apoptosis, necrosis, tumor proliferation and immunologic response, will be assessed following HSV-tk + valacyclovir treatment."
  • "Blood samples will be taken for systemic immunological response, blood counts and liver functions tests."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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.

Study sites (1)

TX