Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00911118
First received: May 28, 2009
Last updated: April 4, 2013
Last verified: April 2013
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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:
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 month & every 3 months and then Every 6 months for months 30-60 ] [ 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: one month post-treatment, then every 3 months for months 3 - 24., in .months 30 - 60 clinical evaluation will be every 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (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.
|
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
- Whole body bone scan negative for metastatic disease
- International Prostate Symptom Score < or = to 15
Exclusion Criteria:
Prior androgen deprivation therapy for prostate cancer
- Elective pelvic lymph node irradiation
- KPS < 70
- Endorectal coil MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
- Presence of distant metastasis
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911118
Contacts
| Contact: Michael Zelefsky, MD | 212-639-6802 | |
| Contact: Marisa Kollmeier, MD | 212-639-3952 |
Locations
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Madhur Garg, MD 718-920-4140 | |
| Principal Investigator: Madhur Garg, MD | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Michael Zelefsky, MD 212-639-6802 | |
| Contact: Marisa Kollmeier, MD 212-639-3952 | |
| Principal Investigator: Michael Zelefsky, MD | |
| Memorial Sloan-Kettering at Mercy Medical Center | Recruiting |
| Rockville Centre, New York, United States | |
| Contact: Michael Zelefsky, MD 212-639-6802 | |
| Memoral Sloan Kettering Cancer Center@Phelps | Recruiting |
| Sleepy Hollow, New York, United States | |
| Contact: Michael Zelefsky, MD 212-639-6802 | |
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:
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: | April 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
prostate radiation 09-035 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013