A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate

Date de début de l'étude : 1 avril 1997

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.