Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

NCT ID: NCT01923506

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-25
• Study Completion Date: 2026-07-28

Brief Summary

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5 fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate fossa.

SECONDARY OBJECTIVES:

I. To assess acute and late toxicities from treatment.

II. To assess biochemical progression-free survival.

III. To collect prospective quality-of-life data related to bowel, urinary, and sexual health.

OUTLINE: This is a dose-escalation study.

Patients receive 5 fractions of SBRT over 1.5 weeks.

After completion of study treatment, patients are followed up at 90 days and then periodically for 3 years.

Conditions

Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (SBRT)

Patients receive 5 fractions of SBRT over 1.5 weeks.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo SBRT

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

stereotactic body radiation therapy

Undergo SBRT

Intervention Type: RADIATION

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy; quality of life assessment

Eligibility Criteria

Inclusion Criteria

• History of diagnosis of prostate cancer after undergoing prostatectomy
• No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic
• Eastern Cooperative Oncology Group (ECOG) performance scale 0-2
• Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
• Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry
• PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion
• All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Patients should not have any uncontrolled illness including ongoing or active infection
• Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy
• Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years
• Study-specific exclusions:

• History of prior radiation to the pelvis
• History of uncontrolled inflammatory bowel disease
• Unable to comply with radiation therapy procedures
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sagus Sampath

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2013-01613

Identifier Type: REGISTRY

Identifier Source: secondary_id

13257

Identifier Type: OTHER

Identifier Source: secondary_id

13257

Identifier Type: -

Identifier Source: org_study_id