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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery | Clinical Trials | Clareo Health

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

Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study

NCT01923506•City of Hope Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

November 25, 2013

Primary Completion Date

July 28, 2026

Completion Date

July 28, 2026

Last Updated

November 26, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent Prostate CancerStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate CancerStage III Prostate Cancer

Interventions

stereotactic body radiation therapy

RADIATION

quality-of-life assessment

PROCEDURE

laboratory biomarker analysis

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Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

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