Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00911118 |
Recruitment Status :
Active, not recruiting
First Posted : June 1, 2009
Last Update Posted : June 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer Adenocarcinoma | Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation | Phase 1 |
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 |

Arm | Intervention/treatment |
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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.
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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. |
- 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. ]
- 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) ]

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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 |
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.
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Low risk patients will be defined as:
- PSA < or = to 10 ng/ml and
- Gleason score = 6 and
- Clinical Stage < or = to T2a
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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:
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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
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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
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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)

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
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 |
Principal Investigator: | Michael Zelefsky, MD | Memorial Sloan Kettering Cancer Center |
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 |
prostate radiation 09-035 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |