Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer

The purpose of this study is to determine the ability of hyperthermia (heat treatments
produced by sound waves) when combined with radiation therapy and in some patients hormonal
therapy to control prostate cancer.

Hyperthermia refers to the use of temperatures 42 oC (107-6oF) or higher to treatment
malignant tumors. Laboratory and some clinical reports have demonstrated a tumor killing
effect if tumors are heated to 43oC (109oF) for 30-60 minutes.

Many studies have shown that hyperthermia improves the killing effect of radiation
treatments for many tumors. In clinical studies, the addition of hyperthermia has shown to
be beneficial for tumors of the breast, urinary bladder and the head and neck region with
combined with radiation therapy. Investigators found an improvement in tumor response rates
and a lengthened duration of response. The proposed study is one of the first controlled
studies to attempt to prove the usefulness of hyperthermia for patients with prostate
cancer.

Inclusion Criteria

- Histologic confirmation of prostate cancer. (Slides will be obtained for central
review)

- Clinical stage T2b, T2c, T3a, or T3b disease as defined by the AJCC 4th edition
staging manual (see Appendix A)

- No evidence of metastatic disease (bone, lymph node or visceral) based on bone scan
and computed tomography

- Adequate hematologic function

- WBC> 4000/mm3

- platelet count > 100, 000/mm3

- hematocrit of > 30%

- An ECOG Performance Status of zero or one

- Age ≥ 18

- A life expectancy of 5 years or more(excluding possible prostate related causes)

Exclusion Criteria :

- Prior history of malignancy (except for non-melanoma skin cancer)

- Prior systemic therapy

- No prior chemotherapy

- No prior hormonal therapy other than that recommended in this protocol

- Prior pelvic radiotherapy

- Medical problems (such as an abnormal bleeding propensity) which would make
transrectal ultrasound-directed transperineal thermal probe placement hazardous.

- Patients with severe insulin-dependent diabetes mellitus and evidence of neuropathy
or vaculopathy

- Patients with unstable cardiac status including:

- Unstable angina pectoris on medication

- Patients with documented myocardial infarction within six months of protocol
entry

- Congestive heart failure requiring medication

- Patients on anti-arrhythmic drugs

- Severe hypertension (diastolic BP> 100 on medication

- Patients with cardiac pacemakers

- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

- Severe COPD (medication requiring, with FEV 1 < 50% of expected or < 1 liter)

- Individuals who appear unlikely to tolerate the required prolonged stationary
position during treatment due to emotional immaturity or instability or otherwise due
to mental incompetence.