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

NCT01923506 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: 13257NCI-2013-01613
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0

  Up to 90 days

• Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0

  Up to 3 years

• Biochemical progression-free survival

  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

  Up to 3 years

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

Patients receive 5 fractions of SBRT over 1.5 weeks.

Radiation: stereotactic body radiation therapy; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Interventions

stereotactic body radiation therapy RADIATION

Undergo SBRT

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Treatment (SBRT)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (SBRT)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (SBRT)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sagus Sampath

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: November 25, 2013
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)