Stereotactic Body Radiation Therapy in Treating Patients With Low- and Intermediate-Risk Prostate Cancer

NCT01737151 | Terminated DMC

• 2 other identifiers: MCC-14712NCI-2012-02545
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Conditions

Prostate Adenocarcinoma; Stage I Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria

  Will be tested using a continuity corrected chi-square test

  2 years

Secondary Outcomes (4)

• Biochemical failure as defined by the Phoenix definition

  Up to 5 years

• Protocol completion rate

  Up to 5 years

• Patient-reported outcomes

  Up to 5 years

• Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria

  Up to 90 days

Study Arms (2)

Arm I (standard stereotactic body radiation therapy (SBRT)

ACTIVE COMPARATOR

Patients undergo standard daily fractions of SBRT over 7-8.5 weeks

Radiation: stereotactic body radiation therapy

Arm II (four fraction split-course SBRT)

EXPERIMENTAL

Patients undergo 2 fractions of SBRT in weeks 1 and 4

Radiation: four fraction split-course SBRT

Interventions

stereotactic body radiation therapy RADIATION

Undergo SBRT

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

Arm I (standard stereotactic body radiation therapy (SBRT)

four fraction split-course SBRT RADIATION

four fraction split-course SBRT

Arm II (four fraction split-course SBRT)

Eligibility Criteria

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

You may qualify if:

• Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
• Low-risk disease - Histopathology score (Gleason sum): =\<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: \<10
• Intermediate-risk disease as either:
• Histopathology score (Gleason sum) =\< 6, T-stage (per current American Joint Committee on Cancer \[AJCC\] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) \> 10 but =\< 20; or
• Histopathology score (Gleason sum) 7 with =\< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA \< 10
• Charlson index of comorbidity score =\< 4
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
• Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
• Patients with a history of pelvic irradiation for any reason
• Life expectancy \< 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
• Prior radiation therapy, brachytherapy, or cryotherapy
• Prior surgical procedure involving peri-rectal and peri-prostatic area

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (3)

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, 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

Study Officials

• Timothy J Harris, M.D.

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: March 8, 2013
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

US (3)