Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

San Diego Radiosurgery

Status and phase: Unknown; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: Stereotactic Radiosurgery using the Novalis Tx

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969202

SDRS0001

Details and patient eligibility

About

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the prostate
• Gleason score ≤ 6 and low volume Gleason 7 (3+4)
• PSA < 10
• Clinical Stage of T2a or less
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Prior radiation treatment for prostate cancer
• Gleason score > 7
• PSA > 10
• Clinical Stage of T2b or greater

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Stereotactic Radiosurgery using NovalisTx

Experimental group

Description:

Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.

Treatment:

Radiation: Stereotactic Radiosurgery using the Novalis Tx