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Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00124917
First received: July 27, 2005
Last updated: August 1, 2014
Last verified: July 2014
  Purpose

BACKGROUND:

-This study represents a progression from findings in four previous NCI ROB protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain MR biological images and co-register tissue in prostate cancer patients.

OBJECTIVES:

-The scientific objective of this protocol is to determine the maximum tolerated dose (MTD) of external beam radiation to regions of interest within the prostate based acute toxicity.

Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.

ELIGIBILITY:

-Patients with prostate cancer without evidence of metastasis will be eligible for this study.

DESIGN:

  • This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients.
  • Anatomic MRI and MR biological images, such as MRS, will be obtained Tissue will be acquired from sites of interest, with biopsy locations precisely translated (co-registered) to an MR image of reference. Tissue samples will be processed for cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI. A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy. If necessary, additional fiducial markers will be placed for target localization during treatment.
  • Once MR guided biopsies are obtained and fiducial markers placed, the patient will undergo a standard CT simulation for radiation therapy treatment planning. The MR and CT images will be fused. Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (7560 cGy.)
  • The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years.

Condition Intervention Phase
Prostate Cancer
Radiation: Radiation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Image Guided Dose Escalation With Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The scientific objective of this protocol is to determine the maximum tolerated dose (MTD) of external beam radiation to regions of interest within the prostate based acute toxicity. [ Time Frame: 12 weeks after RT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
125% prescription to path confirmed tumor; 115% prescrition to areas of image abnormality
Radiation: Radiation
Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 cGy in 180 cGy daily fractions.[1]
Experimental: II
138%prescription to path confirmed tumor; 125% prescrition to areas of image abnormality
Radiation: Radiation
Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 cGy in 180 cGy daily fractions.[1]
Experimental: III
150% prescription to path confirmed tumor; 138%prescrition to areas of image abnormality
Radiation: Radiation
Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 cGy in 180 cGy daily fractions.[1]
Experimental: IV
165% prescription to path confirmed tumor; 150% prescrition to areas of image abnormality
Radiation: Radiation
Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 cGy in 180 cGy daily fractions.[1]
Experimental: V
180% prescription to path confirmed tumor; 165% prescrition to areas of image abnormality
Radiation: Radiation
Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 cGy in 180 cGy daily fractions.[1]
Experimental: VI
200% prescription to path confirmed tumor; 180% prescrition to areas of image abnormality
Radiation: Radiation
Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (as per the Radiation Therapy Oncology Group (RTOG) 9406 study) 7560 cGy in 180 cGy daily fractions.[1]

Detailed Description:

BACKGROUND:

-This study represents a progression from findings in four previous NCI ROB protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain MR biological images and co-register tissue in prostate cancer patients.

OBJECTIVES:

  • The scientific objective of this protocol is to determine the maximum tolerated dose (MTD) of external beam radiation to regions of interest within the prostate based acute toxicity.
  • Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.

ELIGIBILITY:

-Patients with prostate cancer without evidence of metastasis will be eligible for this study.

DESIGN:

  • This phase I trial will use intensity modulated radiation therapy (IMRT) to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer. The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients.
  • Anatomic MRI and MR biological images, such as MRS, will be obtained Tissue will be acquired from sites of interest, with biopsy locations precisely translated (co-registered) to an MR image of reference. Tissue samples will be processed for cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI. A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy. If necessary, additional fiducial markers will be placed for target localization during treatment.
  • Once MR guided biopsies are obtained and fiducial markers placed, the patient will undergo a standard CT simulation for radiation therapy treatment planning. The MR and CT images will be fused. Areas of pathologically confirmed malignancy will undergo dose escalation as described below. Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses. The remainder of the prostate gland will receive standard dose (7560 cGy.)
  • The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. ECOG performance status of 0, 1 or 2
    2. Pathology report confirming adenocarcinoma of the prostate
    3. Risk of lymph node metastasis less than 10% as defined by the Partin tables
    4. Tumor visible on MRI
    5. No prior surgery, radiation, or chemotherapy for prostate cancer.
    6. Age greater than 18 y/o and less than 90 years old.

EXCLUSION CRITERIA:

  1. Cognitively impaired patients who cannot give informed consent.
  2. Patients with metastatic disease.
  3. Contraindication to biopsy

    • Bleeding disorder
    • PT/PTT greater than or equal to 1.5 times the upper limit of normal
    • Platelets less than or equal to 50K
    • Artificial heart valve
  4. Contraindication to MRI

    • Patients weighing greater than 136 kgs (weight limit for the scanner tables)
    • Allergy to MR contrast agent
    • Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.
  5. Pre-existing and active prostatitis or proctitis
  6. Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
  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: NCT00124917

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Aradhana Kaushal, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00124917     History of Changes
Obsolete Identifiers: NCT00227799
Other Study ID Numbers: 050191, 05-C-0191
Study First Received: July 27, 2005
Last Updated: August 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Prostate Cancer
MRI
Fiducial Marker
IMRT

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014