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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 16, 2021
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Adenocarcinoma Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Actual Study Start Date : May 2009
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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) ]
  2. Evaluate pathologic response rates at 24-36 months via repeat biopsy. [ Time Frame: 24-36 months post treatment ]
  3. Evaluate the effect of treatment on sexual function. [ Time Frame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911118


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Montefiore Medical Center
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00911118    
Other Study ID Numbers: 09-035
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
prostate
radiation
09-035
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases