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

Primary Purpose

Prostate Cancer, Adenocarcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated, image-guided, intensity-modulated external beam radiation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, radiation, 09-035

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Montefiore Medical Center
  • Memorial Sloan Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering West Harrison
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering at Mercy Medical Center
  • Memorial Sloan Kettering Cancer Center@Phelps
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.

Secondary Outcome Measures

Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.
Evaluate pathologic response rates at 24-36 months via repeat biopsy.
Evaluate the effect of treatment on sexual function.

Full Information

First Posted
May 28, 2009
Last Updated
September 15, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00911118
Brief Title
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Official Title
A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2009 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Montefiore Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Adenocarcinoma
Keywords
prostate, radiation, 09-035

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Hypofractionated, image-guided, intensity-modulated external beam radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
Evaluate pathologic response rates at 24-36 months via repeat biopsy.
Time Frame
24-36 months post treatment
Title
Evaluate the effect of treatment on sexual function.
Time Frame
1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean McBride, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center@Phelps
City
Sleepy Hollow
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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