High-Dose Stereotactic Radiation for Prostate Cancer

NCT01664130 | Completed Results DMC

• 2 other identifiers: CASE1812NCI-2012-01252
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

  Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

  1.5 months

• Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

  Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

  4 months

• Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

  Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

  8 months

• Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

  Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

  12 months

Secondary Outcomes (12)

• Quality of Life as Assessed by EPIC Scores

  Baseline and 1.5 months

• Quality of Life as Assessed by EPIC Scores

  Baseline and 4 months

• Quality of Life as Assessed by EPIC Scores

  Baseline and 8 months

• Quality of Life as Assessed by EPIC Scores

  Baseline and 12 months

• Quality of Life as Assessed by Change in AUA Scores

  Baseline and 1.5 months

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.

Radiation: stereotactic body radiation therapy; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Interventions

stereotactic body radiation therapy RADIATION

Undergo SBRT

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Treatment (SBRT)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (SBRT)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (SBRT)

Eligibility Criteria

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

You may qualify if:

• The patient must have prostate adenocarcinoma proven by histologic diagnosis
• The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation
• Performance status - Karnofsky performance status (PS) \>= 70
• Life expectancy of \> 5 years, in the opinion of and as documented by the investigator
• Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR \< 2.0).
• Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to enrollment
• Men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment
• Subjects must have the ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Prior treatment toxicities must be resolved to =\< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• Patients who are receiving any other investigational agents
• Evidence of metastatic disease prior to radiation
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Prior pelvic radiation therapy
• Patients whom are planned to receive pelvic nodal radiation are excluded
• Weight \> 350 lbs
• Contraindications to placement of fiducials required for high-precision image guidance (e.g. bleeding disorders which may cause excessive bleeding with placement, requirement for coumadin, international normalized ratio \[INR\] \> 2.0)
• Patients unable to maintain a full bladder during treatment
• Previous prostatectomy
• Inflammatory bowel disease
• AUA score \> 15 in spite of optimal therapy

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Parsai S, Juloori A, Sedor G, Reddy CA, Thousand R, Magnelli A, Berglund RK, Stovsky M, Klein EA, Tendulkar RD, Stephans KL. Heterogenous Dose-escalated Prostate Stereotactic Body Radiation Therapy for All Risk Prostate Cancer: Quality of Life and Clinical Outcomes of an Institutional Pilot Study. Am J Clin Oncol. 2020 Jul;43(7):469-476. doi: 10.1097/COC.0000000000000693.

  PMID: 32349020 DERIVED

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: Kevin Stephans MD
• Organization: Case Comprehensive Cancer Center

stephak@ccf.org

216-445-8285

Study Officials

• Kevin Stephans

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer 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

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 14, 2012
• Study Start: July 1, 2012
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: May 21, 2020
• Results First Posted: September 18, 2019

Record last verified: 2020-05

Locations

US (1)