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

Phase 1
18 Years
85 Years
Open (Enrolling)
Prostate Cancer, Adenocarcinoma

Thank you

Trial Information

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

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

- Endorectal coil MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1

- Presence of distant metastasis as determined by:

o alkaline phosphatase < LLN or

- whole body bone scan negative 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

With at least one status check visit during the course of treatment.

Safety Issue:


Principal Investigator

Michael Zelefsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma
  • prostate
  • radiation
  • 09-035
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Montefiore Medical Center Bronx, New York  10467-2490
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York  
Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow, New York