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Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer


Radiosurgery should be ideal for treating prostate cancer because:

- targeting accuracy for static targets is excellent, with an error of about 1mm,

- it can adjust for intra-fractional organ motion, reducing the volume of the target PTV
and therefore the dose to surrounding organs,

- by using over one-hundred non-conplanar beams, the dose gradient between the prostate
and surrounding tissues may be superior to that achieved with conventional linear
accelerators,

- the radiobiology of prostate cancer may favor large dose per fractions.


Inclusion Criteria:



- Histologically proven prostate adenocarcinoma

- Gleason score 2-7

- Biopsy within one year of date of registration

- Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)

- T-stage and N-stage determined by physical exam and available imaging studies
(ultrasound, CT, and/or MRI)

- M-stage determined by physical exam, CT or MRI. Bone scan not required unless
clinical findings suggest possible osseous metastases.

- PSA ≤ 20 ng/dL

- Patients belonging in one of the following risk groups:

- Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or

- Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and
PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL

- Prostate volume: ≤ 100 cc

- Determined using: volume = π/6 x length x height x width

- Measurement from CT or ultrasound ≤90 days prior to registration.

- ECOG performance status 0-1

- Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26
questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices
questionnaire

- Consent signed.

Exclusion Criteria:

- Prior prostatectomy or cryotherapy of the prostate

- Prior radiotherapy to the prostate or lower pelvis

- Implanted hardware or other material that would prohibit appropriate treatment
planning or treatment delivery, in the investigator's opinion.

- Chemotherapy for a malignancy in the last 5 years.

- History of an invasive malignancy (other than this prostate cancer, or basal or
squamous skin cancers) in the last 5 years.

- Hormone ablation for two months prior to enrollment, or during treat

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher GI and GU toxicity observed during a 24 month follow up

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Dwight E Heron, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

09-031

NCT ID:

NCT00977860

Start Date:

October 2010

Completion Date:

December 2023

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Stereotactic
  • Radiosurgery
  • Prostatic Neoplasms

Name

Location

UPMC Shadyside Radiation Oncology Pittsburgh, Pennsylvania  15232