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

July 27, 2005
August 1, 2014
July 2005
March 2011   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00124917 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer
A Phase I Study of Image Guided Dose Escalation With Intensity Modulated Radiation Therapy (IMRT) to Histologically Confirmed Regions of Prostate Cancer

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
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: I
    125% prescription to path confirmed tumor; 115% prescrition to areas of image abnormality
    Intervention: Radiation: Radiation
  • Experimental: II
    138%prescription to path confirmed tumor; 125% prescrition to areas of image abnormality
    Intervention: Radiation: Radiation
  • Experimental: III
    150% prescription to path confirmed tumor; 138%prescrition to areas of image abnormality
    Intervention: Radiation: Radiation
  • Experimental: IV
    165% prescription to path confirmed tumor; 150% prescrition to areas of image abnormality
    Intervention: Radiation: Radiation
  • Experimental: V
    180% prescription to path confirmed tumor; 165% prescrition to areas of image abnormality
    Intervention: Radiation: Radiation
  • Experimental: VI
    200% prescription to path confirmed tumor; 180% prescrition to areas of image abnormality
    Intervention: Radiation: Radiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2011
March 2011   (final data collection date for primary outcome measure)
  • 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.
Male
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00124917
050191, 05-C-0191
Not Provided
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Aradhana Kaushal, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP