Clinical trial NCT00911118: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Adenocarcinoma
Keywords: prostate
radiation
09-035
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
First posted: 2009-06-01
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.
timeFrame: With at least one status check visit during the course of treatment.
Secondary outcomes:
measure: Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.
timeFrame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
measure: Evaluate pathologic response rates at 24-36 months via repeat biopsy.
timeFrame: 24-36 months post treatment
measure: Evaluate the effect of treatment on sexual function.
timeFrame: 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center@Phelps
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sean McBride, MD
role: PRINCIPAL_INVESTIGATOR
References: