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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Irving Kaplan, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003045
First received: November 1, 1999
Last updated: April 25, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Prostate Cancer
Device: Hyperthermia
Radiation: XRT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Time of PSA Failure [ Time Frame: 2 Years ]
    Kaplan Meier estimation and Cox regression model


Secondary Outcome Measures:
  • Local Control and Disease Specific survival [ Time Frame: One year post treatment ]
    Local Control and Disease Specific survival


Enrollment: 38
Study Start Date: April 1997
Study Completion Date: December 31, 2003
Primary Completion Date: December 31, 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperthermia
XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)
Device: Hyperthermia
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
Radiation: XRT
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
Other Name: Radiation Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003045

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Irving Kaplan, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Irving Kaplan, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00003045     History of Changes
Other Study ID Numbers: 94-153
P30CA006516 ( US NIH Grant/Contract Award Number )
NCI-H97-1294
Study First Received: November 1, 1999
Last Updated: April 25, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Dana-Farber Cancer Institute:
adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Fever
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 26, 2017