Prostate CancerNCT00003045
Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
A study testing Hyperthermia and XRT in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hyperthermia and XRT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1997to 31 Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Hyperthermia, XRT
- Keywords
- adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaDevice
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
XRTRadiation
Also called Radiation Therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia | Experimental | XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months) Receives: Device: Hyperthermia; Radiation: XRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of PSA Failure
Kaplan Meier estimation and Cox regression model
Measured: 2 Years
Secondary outcomes (1)
Local Control and Disease Specific survival
Local Control and Disease Specific survival
Measured: One year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2003 (estimated)
- Study startApr 1997
- Primary completion31 Dec 2001
- Study completion31 Dec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Irving Kaplan, Dana-Farber Cancer Institute
- Investigators
- Irving Kaplan, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003045
- Sponsor's protocol ID
- 94-153
- Other IDs
- P30CA006516, NCI-H97-1294
- Status last verified
- Apr 2017
- First submitted
- 1 Nov 1999
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12095557Hurwitz 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.
PubMed 11212878
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00003045
- Acronym / sponsor ID
- 94-153
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1997
- Primary completion
- 31 Dec 2001 (actual)
- Study completion
- 31 Dec 2003 (actual)
- First posted
- 11 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia | Experimental | Device: Hyperthermia, Radiation: XRTXRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- An ECOG Performance Status of zero or one
Key exclusion criteria (17 listed)
- Prior history of malignancy (except for non-melanoma skin cancer)
- Prior systemic therapy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperthermiaHyperthermia 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 | Device | Hyperthermia |
| XRTAlso: Radiation Therapyexternal 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 | Radiation | Hyperthermia |
Primary outcome
Time of PSA Failure
Time frame: 2 Years
Kaplan Meier estimation and Cox regression model
1 secondary outcome
Local Control and Disease Specific survival
Time frame: One year post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 12095557Hurwitz 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.
- Background: PubMed 11212878Hurwitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irving Kaplan, MD study chair
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia and XRT in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of PSA Failure (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.