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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperthermia
XRT
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperthermia

Arm Description

XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)

Outcomes

Primary Outcome Measures

Time of PSA Failure
Kaplan Meier estimation and Cox regression model

Secondary Outcome Measures

Local Control and Disease Specific survival
Local Control and Disease Specific survival

Full Information

First Posted
November 1, 1999
Last Updated
April 25, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003045
Brief Title
Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
Official Title
A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
December 31, 2001 (Actual)
Study Completion Date
December 31, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperthermia
Arm Type
Experimental
Arm Description
XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)
Intervention Type
Device
Intervention Name(s)
Hyperthermia
Intervention Description
Hyperthermia is delivered by the transrectal ultrasound applicator just prior to XRT, at least one week apart, during the first 4 weeks of XRT. The goal of hyperthermia is CEM T 90 43 greater than or equal to 10 minutes. The maximum applied power duration will be 120 minutes per treatment session
Intervention Type
Radiation
Intervention Name(s)
XRT
Other Intervention Name(s)
Radiation Therapy
Intervention Description
external beam radiation to a dose of 4500 cGy to a small pelvic field, followed by a boost to a reduced volume for an additional 2160 cGy. XRT is given daily, 5 days a week for 180 cGy per day. Total radiation dose=6660cGy
Primary Outcome Measure Information:
Title
Time of PSA Failure
Description
Kaplan Meier estimation and Cox regression model
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Local Control and Disease Specific survival
Description
Local Control and Disease Specific survival
Time Frame
One year post treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irving Kaplan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12095557
Citation
Hurwitz 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.
Results Reference
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PubMed Identifier
11212878
Citation
Hurwitz 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.
Results Reference
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Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer

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