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Completed

NCT Number: NCT00977860

Hypofractionated SBRT For Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hillman Cancer Center - Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

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

Other names: CyberKnife, Trilogy, True Beam, Radiosurgery

Primary outcomes

  1. Rate of Acute Grade 3 or Higher GI and GU Toxicities

    Time frame: Up to 90 days

    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.

  2. Rate of Late Grade 3 or Higher GI and GU Toxicities

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

    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.

  3. Biochemical Disease-Free Survival Rate (bDFS)

    Time frame: Up to 5 years

    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.

Secondary outcomes

  1. Rate of Local Failure

    Time frame: Up to 5 years

    Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy.

  2. Rate of Distant Failure

    Time frame: Up to 5 years

    Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area).

  3. 5-year Overall Survival (OS)

    Time frame: At 5 years

    Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.

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

    Time frame: Prior to start of therapy

    The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.

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

    Time frame: At 24 months (post-start of therapy)

    The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.

Sponsors and collaborators

Lead sponsor

Adam Olson

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2009
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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