A Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile

Inclusion Criteria:

- Men with histologically-confirmed adenocarcinoma of the prostate within 180 days
prior to registration. To be eligible, the subjects must have one of the following
conditions:

- Stage T1 or T2, Gleason Score 7, PSA <= 20 ng/mL, Any number positive biopsy
cores

- Stage T1 or T2, Gleason Score 5 or 6, PSA >=10 ng/mL and <20 ng/mL, Any number
positive biopsy cores

- Stage T1 or T2, Gleason Score 5 or 6, PSA <10 ng/mL and >=50% positive biopsy
cores

- Negative lymph nodes as established by imaging, nodal sampling, or dissection within
90 days prior to registration.

- No evidence of metastatic disease as evaluated by bone scan and CT scan of the
abdomen and pelvis within 90 days prior to registration

- Karnofsky performance status >=70

- Subjects must have adequate baseline organ function, as assessed by the following
laboratory values, within 30 days before initiating the study

- Adequate renal function with serum creatinine <=1.5 mg/dL or creatinine clearance
>=45 mL/min/m2.

- Platelet count > 100,000/μL.

- Absolute neutrophil count > 1,000/μL.

- Hemoglobin > 10.0 g/dL.

- Normal partial thromboplastin time (PTT) and prothrombin (PT).

- Bilirubin < 1.5 mg/dL; SGOT and SGPT < 2.5 times upper limit of normal (ULN).

- Men of child-producing potential must be willing to consent to use effective
contraception while on treatment and for at least 3 months afterwards.

- Subjects must possess the ability to give informed consent and express a willingness
to meet all of the expected requirements of the protocol for the duration of the
study.

Exclusion Criteria:

Subjects with the following conditions will be excluded from the study:

- Stage >= T3.

- PSA > 20 ng/mL.

- Gleason score >= 8.

- Prostate volume >120cc.

- Pathologically positive lymph nodes or nodes > 1.5 cm on imaging. Note: nodes > 1.5
cm but biopsy negative are allowed.

- Evidence of M1 metastatic disease.

- Prior invasive malignancy except for non-melanoma skin cancer within 5 years of
enrollment.

- Prognosis for survival of < 5 years.

- Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral
orchiectomy for any reason.

- Prior radiotherapy, including brachytherapy, to the region of the study cancer that
would result in overlap of radiation fields.

- Prior or planned androgen suppression therapy or prior systemic chemotherapy for the
study cancer. Note that prior chemotherapy for a different cancer is allowed;
however, patients must be >2 years post-completion of chemotherapy at time of
registration. Patients on Proscar therapy must stop to be eligible.

- Severe, active co-morbidity defined as:

- Unstable angina and/or congestive heart failure requiring hospitalization within the
last 6 months.

- Transmural myocardial infarction within the last 6 months.

- Acute infection. Acute infection is defined by any viral, bacterial, or fungal
infection that requires specific therapy within 72 hours of initiation of the study
therapy.

- Positive serological test for HIV at baseline.

- Previous history of liver disease including hepatitis.

- Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and
topical corticosteroids is permitted.

- Impaired immunity or susceptibility to serious viral infections.

- Allergy to any product used in the protocol. (If the subject has an allergy to
Ciprofloxacin, another antibiotic can be substituted at the discretion of the
treating physician.

- Serious medical or psychiatric illness or concomitant medication, which, in the
judgment of the principal investigator, might interfere with the subject's ability to
respond to or tolerate the treatment or complete the trial.