Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334579
• Other study ID #: IR 5642
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2024

Study information

• Verified date: July 2019
• Source: Swedish Medical Center
• Contact: Mary Monahan
• Phone: (206) 320-7129
• Email: mary.monahan[@]swedish.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Neoplasms
• Prostate Cancer
• Prostate Neoplasms
• Prostatic Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• CyberKnife Stereotactic Radiosurgery
Five treatments given over about one week.

Locations

Country	Name	City	State
United States	Swedish Medical Center Radiosurgery Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Measure quality of life after five years following cyberknife stereotactic radiosurgery.	5 years
Primary	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
Primary	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	Rates of toxicities related to treatment	After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.	5 years
Secondary	Disease free survival	Measure disease free survival after five years following cyberknife stereotactic radiosurgery.	5 years
Secondary	Overall survival	Measure overall survival after five years following cyberknife stereotactic radiosurgery.	5 years

External Links

•   Swedish Medical Center Radiosurgery Center