Hyperthermia and High Dose Rate Radiation Therapy in Treating Patients With Recurrent Prostate Cancer After Radiation

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of combined single fraction high dose rate (HDR)
brachytherapy followed immediately by interstitial hyperthermia treatment of radio-recurrent
prostate cancer.

SECONDARY OBJECTIVES:

I. To assess long-term toxicity. II. To provide a preliminary assessment of efficacy. III. To
obtain blood for future analysis of immune response to combined radiation therapy and
hyperthermia.

Inclusion Criteria:

- Karnofsky performance status > 70%

- Expected survival of at least 3 years

- Informed consent signed by the subject

- Prostate-specific antigen (PSA) blood test within 60 days prior to registration

- Prostate biopsy with Gleason score and TNM staging within one year prior to
registration

- No evidence of metastasis on computed tomography (CT) or magnetic resonance imaging
(MRI) of the pelvis within 120 days prior to registration.

- No evidence of metastasis on bone scan within 120 days prior to registration

- Within 60 days prior to registration, hematologic minimal values: absolute neutrophil
count > 1,500/mm^3

- Within 60 days prior to registration, hematologic minimal values: hemoglobin > 8.0
g/dl

- Within 60 days prior to registration, hematologic minimal values: platelet count >
100,000/mm^3

- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months after completion of
treatment

- Histologically proven persistent or recurrent adenocarcinoma of the prostate following
prior external beam radiation therapy or brachytherapy

- Prior Androgen Deprivation or chemotherapy is allowed if discontinued at least 30 days
prior to enrollment

- Concurrent disease - patients under treatment for concurrent medical conditions will
be eligible for protocol treatment if, in the opinion of the physician responsible for
hyperthermia treatment that the concurrent medical condition will neither interfere
with the process of the treatment or patient assessments nor add significantly to the
risks or complications of the treatment

Exclusion Criteria:

- History of urological surgery or procedures predisposing to genitourinary (GU)
complications after radiation, i.e., anastomoses, stricture repair, transurethral
resection, etc. (will be determined by radiation oncologist)

- Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused
ultrasound [HIFU] or cryoablation)

- Documented distant metastatic disease

- Patient with other co-morbidities that in the opinion of the treating physician would
be a contra-indication to protocol participation (e.g. inflammatory bowel disease)

- Mental incompetence or criminal incarceration