Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT01923506|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2013
Last Update Posted : March 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer||Radiation: stereotactic body radiation therapy Procedure: quality-of-life assessment Other: laboratory biomarker analysis||Phase 1|
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.
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 (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study|
|Actual Study Start Date :||November 25, 2013|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: Treatment (SBRT)
Patients receive 5 fractions of SBRT over 1.5 weeks.
Radiation: stereotactic body radiation therapy
Procedure: quality-of-life assessment
Other Name: quality of life assessment
Other: laboratory biomarker analysis
- 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 [ Time Frame: 90 days ]Tables will be created to summarize these toxicities and side effects by dose level.
- Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 90 days ]Tables will be created to summarize these toxicities and side effects by dose level.
- Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]Tables will be created to summarize these toxicities and side effects by dose level.
- Biochemical progression-free survival [ Time Frame: Up to 3 years ]Estimated using Kaplan-Meier. 95% confidence intervals should be provided.
- Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires [ Time Frame: Up to 3 years ]Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923506
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Sagus Sampath||City of Hope Medical Center|
|Responsible Party:||City of Hope Medical Center|
|Other Study ID Numbers:||
NCI-2013-01613 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13257 ( Other Identifier: City of Hope Medical Center )
|First Posted:||August 15, 2013 Key Record Dates|
|Last Update Posted:||March 2, 2023|
|Last Verified:||March 2023|
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