Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

NCT02334579 | Unknown

• 1 other identifier: IR 5642
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

Conditions

Prostate Cancer; Prostatic Cancer; Prostate Neoplasms; Prostatic Neoplasms; Cancer of the Prostate

Keywords

Radiation; Stereotactic Radiosurgery; Radiotherapy; Prostate Tumor; Prostate Surgery; CyberKnife

Outcome Measures

Primary Outcomes (2)

• Quality of life outcomes (low- and intermediate-risk prostate cancer groups)

  In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.

  8 years

• Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)

  In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.

  8 years

Secondary Outcomes (3)

• Rates of toxicities related to treatment

  5 years

• Disease free survival

  5 years

• Overall survival

  5 years

Other Outcomes (1)

• Quality of life

  5 years

Study Arms (1)

CyberKnife Stereotactic Radiosurgery

EXPERIMENTAL

This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.

Radiation: CyberKnife Stereotactic Radiosurgery

Interventions

CyberKnife Stereotactic Radiosurgery RADIATION

Five treatments given over about one week.

CyberKnife Stereotactic Radiosurgery

Eligibility Criteria

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

You may qualify if:

• Histologically proven prostate adenocarcinoma
• Clinical stage T1a-T3, N0-Nx, M0-Mx
• Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA\<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA\<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 \& \<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
• Karnofsky performance status 70-100
• Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
• Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
• High risk group: three hormone therapy regimens are allowed
• alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

You may not qualify if:

• Prior prostatectomy or cryotherapy of the prostate
• Prior high-dose 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

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (1)

Swedish Medical Center Radiosurgery Center

Seattle, Washington, 98122, United States

RECRUITING

Related Links

• Swedish Medical Center Radiosurgery Center

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

• Robert Meier, MD

  Swedish Medical Center Radiosurgery Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Monahan

CONTACT

(206) 320-7129; mary.monahan@swedish.org

Robert Meier, MD

CONTACT

(206) 320-7130; robert.meier@swedish.org

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: December 4, 2014
• First Posted: January 8, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

US (1)