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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Radiation: stereotactic body radiation therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (SBRT); Patients receive 5 fractions of SBRT over 1.5 weeks.	Other: laboratory biomarker analysis; Correlative studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Radiation: stereotactic body radiation therapy; Undergo SBRT; Other Names: SBRT; stereotactic radiation therapy; stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	Tables will be created to summarize these toxicities and side effects by dose level.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0	Tables will be created to summarize these toxicities and side effects by dose level.	Up to 90 days
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0	Tables will be created to summarize these toxicities and side effects by dose level.	Up to 3 years
Biochemical progression-free survival	Estimated using Kaplan-Meier. 95% confidence intervals should be provided.	Up to 3 years
Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires	Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.	Up to 3 years

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sagus Sampath, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2013
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimated): August 15, 2013

Study Record Updates

• Last Update Posted (Estimated): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 13257 (Other Identifier: City of Hope Medical Center); NCI-2013-01613 (Registry Identifier: CTRP (Clinical Trial Reporting Program))