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Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830165
Recruitment Status : Active, not recruiting
First Posted : July 12, 2016
Results First Posted : January 6, 2022
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

Condition or disease Intervention/treatment Phase
Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7 Stage II Prostate Adenocarcinoma AJCC v7 Stage III Prostate Adenocarcinoma AJCC v7 Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Radiation: Stereotactic Body Radiation Therapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.

SECONDARY OBJECTIVES:

I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate Symptom Score [IPSS] questionnaires).

II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.

III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.

OUTLINE:

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : May 9, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (SBRT)
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications [ Time Frame: At 4 weeks post surgery ]

Secondary Outcome Measures :
  1. Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities [ Time Frame: Up to 1 year ]
    Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).

  2. Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring. [ Time Frame: score from baseline to twelve months ]
    The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.

  3. Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire. [ Time Frame: Mean change in I-PSS score from baseline to 12 months. ]
    The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.


Other Outcome Measures:
  1. Correlative Biomarker Analyses Using Tissue and Serial Blood Samples [ Time Frame: Baseline and to up to 1 year ]
    Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
  • Patient desires and is medically fit to undergo prostatectomy
  • Karnofsky performance status (KPS) >= 70
  • Patients on androgen deprivation therapy (ADT) are allowed
  • For confirmation of high risk local failure status, patients will have any one of the following:

    • Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
    • Pre-biopsy prostate-specific antigen (PSA) >= 20
    • Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
    • Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
    • Clinical stage >= T3 (staging by imaging acceptable)
  • An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy

Exclusion Criteria:

  • Distant metastases, based upon:

    • CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
    • Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
  • Patient is unable or unwilling to sign consent
  • Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830165


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nicholas Nickols, MD, PhD UCLA / Jonsson Comprehensive Cancer Center
  Study Documents (Full-Text)

Documents provided by Jonsson Comprehensive Cancer Center:
Informed Consent Form  [PDF] August 28, 2019

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02830165    
Other Study ID Numbers: 15-001580
NCI-2016-00188 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JCCCID608
P50CA092131 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2016    Key Record Dates
Results First Posted: January 6, 2022
Last Update Posted: January 6, 2022
Last Verified: July 2021
Additional relevant MeSH terms:
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Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases