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Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00911118
Recruitment Status : Active, not recruiting
First Posted : June 1, 2009
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE May 28, 2009
First Posted Date  ICMJE June 1, 2009
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE May 2009
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer. [ Time Frame: With at least one status check visit during the course of treatment. ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer. [ Time Frame: weekly during radiation ]
Change History Complete list of historical versions of study NCT00911118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival. [ Time Frame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks) ]
  • Evaluate pathologic response rates at 24-36 months via repeat biopsy. [ Time Frame: 24-36 months post treatment ]
  • Evaluate the effect of treatment on sexual function. [ Time Frame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
  • Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival. [ Time Frame: 1 month & every 3 months and then Every 6 months for 3-5yrs. ]
  • Evaluate pathologic response rates at 24-36 months via repeat biopsy. [ Time Frame: 24-36 months post treatment ]
  • Evaluate the effect of treatment on sexual function. [ Time Frame: one month post-treatment, then every 3 months for 1 - 2 yrs., in 3 - 5 yrs. clinical evaluation will be every 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Official Title  ICMJE A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Brief Summary The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Adenocarcinoma
Intervention  ICMJE Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation
A standard dose escalation design is utilized, with the initial treatment assigned as 6.5 Gy/fraction for five fractions to a total dose of 32.5 Gy. For any given dose tier, an initial cohort of 30 patients will be treated. However to adjust for potentially inevaluable patients who dropout prior to a full toxicity collection to assess potential DLTs enrollment of up to five additional patients per cohort can occur, per PI's discretion. Dose escalation will proceed if < 10% of the 30 patients treated per tier exhibit any dose limiting toxicity (DLT) once the entire tier cohort has a minimum follow-up of 3 months and half the tier cohort has a minimum follow-up of 6 months. Dose escalation to the next tier will occur by increasing the dose per fraction by 0.5 Gy while keeping the fraction number constant at 5, leading to a total dose increase of 2.5 Gy per dose tier.
Study Arms  ICMJE Experimental: Radiation
Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis.
Intervention: Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2012)
120
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2009)
200
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.

  • Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
  • Low risk patients will be defined as:

    • PSA < or = to 10 ng/ml and
    • Gleason score = 6 and
    • Clinical Stage < or = to T2a
  • Intermediate risk patients will be defined as:

    • PSA 10-20 ng/ml or
    • Gleason score = 7 or
    • Clinical stage T2b/T2c

Additionally, patients will be required to meet the following criteria:

  • Age > or = to 18
  • KPS > or = to 70
  • Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
  • Prostate size < or = to 60 cc
  • International Prostate Symptom Score < or = to 15

Exclusion Criteria:

  • Prior androgen deprivation therapy for prostate cancer

    • Elective pelvic lymph node irradiation
    • KPS < 70
    • Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
    • Presence of distant metastasis as determined by:

      o alkaline phosphatase > or = to ULN or

    • whole body bone scan positive for osseous metastases
    • Prior history of transurethral resection of the prostate
    • Prior history of chronic prostatitis
    • Prior history of urethral stricture
    • Prior history of pelvic irradiation
    • History of inflammatory bowel disease
    • Unable to give informed consent
    • Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following

      • Platelet count less than 75,000/ml
      • Hb level less than 10 gm/dl
      • WBC less than 3.5/ml
    • Abnormal renal function tests (creatinine > 1.5)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00911118
Other Study ID Numbers  ICMJE 09-035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Montefiore Medical Center
Investigators  ICMJE
Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2019

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