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

Recurrent Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01923506
• Other study ID #: 13257
• Secondary ID: NCI-2013-0161313
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 25, 2013
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Biochemical progression-free survival	Estimated using Kaplan-Meier. 95% confidence intervals should be provided.	Up to 3 years
Secondary	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