Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Sponsor

Swedish Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02334579

Collaborator

(none)

146

Enrollment

Location

Arm

120

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostatic Cancer Prostate Neoplasms Prostatic Neoplasms Cancer of the Prostate	Radiation: CyberKnife Stereotactic Radiosurgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

146 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CyberKnife Stereotactic Radiosurgery 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 Five treatments given over about one week.

Arm

Intervention/Treatment

Experimental: CyberKnife Stereotactic Radiosurgery

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

Five treatments given over about one week.

Outcome Measures

Primary Outcome Measures

Quality of life outcomes (low- and intermediate-risk prostate cancer groups) [8 years]
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.
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group) [8 years]
In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.

Secondary Outcome Measures

Rates of toxicities related to treatment [5 years]
After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.
Disease free survival [5 years]
Measure disease free survival after five years following cyberknife stereotactic radiosurgery.
Overall survival [5 years]
Measure overall survival after five years following cyberknife stereotactic radiosurgery.

Other Outcome Measures

Quality of life [5 years]
Measure quality of life after five years following cyberknife stereotactic radiosurgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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