Hypofractionated SBRT For Prostate Cancer

NCT00977860 | Completed Results DMC FDA Device

• 1 other identifier: HCC 09-031
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate; Stereotactic; Radiosurgery

Outcome Measures

Primary Outcomes (3)

• Rate of Acute Grade 3 or Higher GI and GU Toxicities

  Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

  Up to 90 days

• Rate of Late Grade 3 or Higher GI and GU Toxicities

  Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

  After 90 days post-treatment, up to 5 years per patient

• Biochemical Disease-Free Survival Rate (bDFS)

  Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA \> 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.

  Up to 5 years

Secondary Outcomes (5)

• Rate of Local Failure

  Up to 5 years

• Rate of Distant Failure

  Up to 5 years

• 5-year Overall Survival (OS)

  At 5 years

• Quality of Life (QoL) - FACT-G - Prior to Therapy

  Prior to start of therapy

• Quality of Life (QoL) - FACT-G - At 24 Months

  At 24 months (post-start of therapy)

Study Arms (1)

SBRT

OTHER

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period

Also known as: CyberKnife, Trilogy, True Beam, Radiosurgery

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adam Olson: lead

Study Sites (1)

UPMC Hillman Cancer Center - Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Barbara M Stadterman, MPH, MCCR
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Adam Olson, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: October 7, 2010
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)