Internal Radiation Therapy in Treating Patients With Low-... | NCT01859689

ID	Type	Description	Link
NCI-2013-00647	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants enrolled

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 4, 2013

First Submission Date that Met QC Criteria

May 20, 2013

First Posted Date

May 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2020

Last Update Posted Date

Jul 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.

SECONDARY OBJECTIVES:

I. To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.

III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.

OUTLINE:

Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment (image-guided HDR brachytherapy)	Experimental	Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.	Radiation: brachytherapy Radiation: image-guided radiation therapy Other: laboratory biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
brachytherapy	Radiation	Undergo image-guided HDR brachytherapy	Treatment (image-guided HDR brachytherapy)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biochemical PSA control using the Phoenix definition of PSA nadir + 2		5 years

Secondary Outcomes

Measure	Description	Time Frame
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0		3 months
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
Unilateral prostate cancer as determined by prostate biopsy
Less than or equal to 3 positive biopsy cores
No biopsy core >= 50% positive for cancer
Karnofsky performance status (KPS) >= 70
At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
Clinical stage T1c or T2a
PSA < 10 ng/ml
Gleason score 3+3=6

Exclusion Criteria:

Patients who have previously received radiation therapy to the pelvis
Refusal to sign the informed consent
Patients who are participating in a concurrent treatment protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitchell Kamrava	Jonsson Comprehensive Cancer Center	Principal Investigator

Locations

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D001918	Brachytherapy
D013812	Therapeutics
D061089	Radiotherapy, Image-Guided