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

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ClinicalTrials.gov Identifier: NCT02830165
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : September 27, 2017
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. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. 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 Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma 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. Correlative biomarker and molecular analyses using the primary tumor specimen and serial blood draws before and after treatment.

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 every 3 months for 1 year.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 : March 10, 2016
Estimated Primary Completion Date : March 10, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: SBRT



Primary Outcome Measures :
  1. Treatment Completion Rate of Pre-Operative stereotactic body radiotherapy (SBRT). [ Time Frame: At 4 weeks ]
    A two-sided 90% exact binomial confidence interval will be used to measure the treatment completion rate.


Secondary Outcome Measures :
  1. Changes in quality of life, based on the International Prostate Symptom Score (I-PSS) questionnaire [ Time Frame: Baseline to up to 1 year ]
  2. 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 stereotactic body radiation therapy (SBRT)

  3. Incidence of toxicities, based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to 1 year ]
  4. Changes in quality of life, based on the Expanded Prostate Cancer Index Composite (EPIC) questionnaire [ Time Frame: Baseline to up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 within 120 days prior to registration and
    • Bone scan 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
United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Nicholas Nickols    310-825-8278    nnickols@mednet.ucla.edu   
Principal Investigator: Nicholas Nickols         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nicholas Nickols UCLA / Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02830165     History of Changes
Other Study ID Numbers: 15-001580
NCI-2016-00188 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JCCCID608
15-001580 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases