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

Purpose

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	Intervention	Phase
Prostate Cancer Adenocarcinoma	Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Evaluate pathologic response rates at 24-36 months via repeat biopsy. [ Time Frame: 24-36 months post treatment ] [ Designated as safety issue: No ]
Evaluate the effect of treatment on sexual function. [ Time Frame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks) ] [ Designated as safety issue: No ]


Estimated Enrollment:	120
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years
Genders 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

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: NCT00911118

Locations


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 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 West Harrison
West Harrison, New York, United States, 10604

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center.

Montefiore Medical Center

Investigators


Principal Investigator:	Michael Zelefsky, MD	Memorial Sloan Kettering Cancer Center.

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Memorial Sloan Kettering Cancer Center.
ClinicalTrials.gov Identifier:	NCT00911118 History of Changes
Other Study ID Numbers:	09-035
Study First Received:	May 28, 2009
Last Updated:	January 19, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:


prostate radiation 09-035

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 February 27, 2015