Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Swedish Medical Center

Status: Enrolling

Conditions: Prostate Neoplasms; Prostatic Neoplasms; Prostatic Cancer; Prostate Cancer; Cancer of the Prostate

Treatments: Radiation: CyberKnife Stereotactic Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02334579

IR 5642

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

CyberKnife Stereotactic Radiosurgery

Experimental group

Description:

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.

Treatment:

Radiation: CyberKnife Stereotactic Radiosurgery