Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Clinicaltrials.gov ID: NCT02334579
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 146

Conditions

Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Robert Meier, MD

Eligibility Criteria

Inclusion Criteria:

* 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
* 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

Exclusion Criteria:

* 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

Study Plan

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

    Description:

    Five treatments given over about one week.

Outcome Measures

Primary Outcome Measures

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

Time Frame: 8 years

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

Time Frame: 8 years

Secondary Outcome Measures

Rates of toxicities related to treatment

Time Frame: 5 years

Disease free survival

Time Frame: 5 years

Overall survival

Time Frame: 5 years

Timeline

  • Last Updated
    July 12, 2019
  • Start Date
    January 8, 2015
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    December 1, 2024

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