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Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

NCT ID: NCT00956228

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

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The current study involves a novel and aggressive therapeutic approach for patients' prostate cancer. In addition, the investigators propose to administer hormonal therapy to patients with an especially high risk: those with initial Gleason scores of \> 6, PSA \> 10 ng/ml, T3/T4 primary tumors, and those found to be node positive (N+). The use of hormonal therapy in these specific settings correlates with our current standard of care. IMRT is better able to spare and protect normal tissues from receiving radiation than 3-D conformal RT. The radiotherapy would be followed by continued hormonal therapy for a total of 6 months in those who have one of the following Gleason 7 and PSA 10-20 and as per the previous version of this trial, 1 year similar to that delivered by the EORTC for higher risk patients, (those with initial Gleason scores of \> 8, PSA \> 20 ng/ml, or T3/T4 tumors). Those found to be N(+) would have the hormonal therapy continued indefinitely or until disease progression occurred in a manner analogous to the Messing et. al. series in prostatectomy patients. The goals are to develop and administer a program of treatment that includes the most recent developments in imaging, integrating data from both the CT scan and the ProstaScint scan to optimize prostate cancer RT. The CT scan will be used for staging and to determine the exact location of the entire prostate which will receive a reasonable dose of RT. The ProstaScint will be used to assess the spread of disease to lymph nodes as well as to determine the exact location of the tumor within the prostate gland. This region will then be boosted to a tumorcidal dose. The investigators then plan to monitor the toxicity and outcome of this treatment. The investigators expect that this program of radioimmunoguided IMRT will likely result in similar or less toxicity and increased cure rates when compared to conventional radiotherapy and standard IMRT programs.

Detailed Description

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Conditions

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Prostatic Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radioimmunoguided IMRT

All patients recieved Intensity Modulated Radiotherapy to the prostate with 75.6 Gy in 42 fractions. Additionally, they recieve a concurrent boost to the region of the prostate which enhanced on the prostascint scan to 82 Gy.

Group Type EXPERIMENTAL

radioimmuniguided intenstiy modulated radiotherapy

Intervention Type RADIATION

All patients recieved 75.6 Gy in 42 fractions to the prostate and the region of the prostate which enhanced on prostascint scan was simaltaneously boosted to a total dose of 82 Gy

Interventions

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radioimmuniguided intenstiy modulated radiotherapy

All patients recieved 75.6 Gy in 42 fractions to the prostate and the region of the prostate which enhanced on prostascint scan was simaltaneously boosted to a total dose of 82 Gy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with pathologically proven prostate cancer
* No evidence of distant metastases (M0) on physical examination, bone scan
* ECOG PS 0,1,2
* Adequate organ function as evidenced by:

* Hemoglobin \> 10.0 gm/dl
* White blood count \> 3000/mcL
* Platelet count \> 90,000/mcL
* AST \< 2x normal
* Age \> 18 years
* Patients can not be allergic to Leuprolide or Goserelin if the pretreatment PSA \> 20, Gleason Score \> 8, T3/4, or N1 disease
* Written informed consent
* We anticipate enrolling at least 50 patients per year, which would bring accrual to projected total of 100 patients in 2 years

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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390-02

Identifier Type: -

Identifier Source: org_study_id