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Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy With Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy With Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer

This is a phase II study designed to prospectively evaluate the efficacy and morbidity of
IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients
with clinically localized prostate cancer will be treated with three radiosurgical
treatments (6.5 Gy per fraction to the PTV) followed by IMRT (45 Gy in 25 fractions).
Treatment will be completed over a 6-7 week period.

The hypothesis is that for patients with clinically localized adenocarcinoma of the
prostate, CyberKnife Radiosurgery delivered to the prostate is efficacious with acceptable
toxicity in combination with IMRT.

Subjects will have toxicity evaluation and AUA score on the last day of treatment. At 1
month following treatment, subjects will be assessed for acute toxicity and will fill out
AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18 and 24
month intervals (and every 6 months thereafter, through year 5, and annually through year
10, if investigators opt to continue past year 5), subjects will be seen and evaluated,
including a history, physical exam, performance status, PSA, toxicity evaluation, and AUA
score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM
and Utilization of Sexual Medications/Devices will be administered. A prostate biopsy will
be performed at time of biochemical or local clinical failure, and is encouraged at 2 years
following treatment and at time of distant failure. A bone scan will be performed at the
time of biochemical failure, or when the subject develops signs of symptoms suggesting
metastatic disease.

Acute side effects (≤ 90 days of treatment start) will be assessed using the NCI Toxicity
Criteria version 3.0.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate (Biopsy within one year of

- Signed Study-Specific COnsent

- PSA within 60 days of registration

- Baseline AUA score is less than 20

Exclusion Criteria:

- Prior Pelvic radiotherapy

- Prior Radical Prostate surgery

- Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer

- Medical or psychiatric illness that would interfere with treatment or follow-up

- Implanted hardware adjacent to the prostate that would prohibit appropriate treatment
planning and/or treatment delivery.

Type of Study:


Study Design:

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

Outcome Measure:

Local failure

Outcome Description:

To estimate the rate of local failure as assessed by 2 year post-radiotherapy prostate biopsies. (Studies with the CyberKnife radiosurgery would be worthwhile for prostate cancer patients if the rate of local control was > 70%)

Outcome Time Frame:

2 years after radiotherapy.

Safety Issue:


Principal Investigator

Sean P Collins, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University Hospital


United States: Institutional Review Board

Study ID:

IRB 2009-599



Start Date:

November 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms



MedStar Georgetown University Hospital Washington, District of Columbia  20007