Clinical trial · Interventional
Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
NCT00003045CI-TRIAL-00027202completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hyperthermia therapy may kill prostate cancer cells by heating them to several degrees above body temperature. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining hyperthermia with radiation therapy may kill more tumor cells. The purpose of this study is to determine the ability of hyperthermia when combined with radiation therapy and in some patients hormonal therapy to control prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia | Device | — | UNRESOLVED |
| XRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperthermia
- description
- XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)
- interventionNames
- Device: Hyperthermia
- Radiation: XRT
Primary outcomes (1)
- measure
- Time of PSA Failure
- timeFrame
- 2 Years
- description
- Kaplan Meier estimation and Cox regression model
Secondary outcomes (1)
- measure
- Local Control and Disease Specific survival
- timeFrame
- One year post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDHurwitz MD, Kaplan ID, Hansen JL, Prokopios-Davos S, Topulos GP, Wishnow K, Manola J, Bornstein BA, Hynynen K. Association of rectal toxicity with thermal dose parameters in treatment of locally advanced prostate cancer with radiation and hyperthermia. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):913-8. doi: 10.1016/s0360-3016(02)02809-2. PMID 12095557
- BACKGROUNDHurwitz MD, Kaplan ID, Svensson GK, Hynynen K, Hansen MS. Feasibility and patient tolerance of a novel transrectal ultrasound hyperthermia system for treatment of prostate cancer. Int J Hyperthermia. 2001 Jan-Feb;17(1):31-7. doi: 10.1080/02656730150201570. PMID 11212878