Proton Beam Radiation Therapy for Early Stage Adenocarcin... | NCT00585962

Studies
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate

NCT00585962

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Sep 5, 2017Actual

Enrollment

57Actual

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Proton Beam Radiation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Dec 27, 2007

First Submission Date that Met QC Criteria

Dec 27, 2007

First Posted Date

Jan 4, 2008Estimated

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

Aug 31, 2017

Last Update Posted Date

Sep 5, 2017Actual

Name	Class
American College of Radiology Imaging Network	NETWORK

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

The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.

Detailed Description

Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.

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

57Actual

Name	Type	Description	Arm Group Labels	Other Names
Proton Beam Radiation	Radiation	Once a day, 5 days a week (Monday-Friday), for 8 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation		3 years

Secondary Outcomes

Measure	Description	Time Frame
To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
Zubrod status 0-1.
No evidence of distant metastasis.
No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.

Exclusion Criteria:

Clinical stages T2c or above.
PSA greater than 15.
Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
Evidence of lymph node involvement if lymph node sampling performed.
Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
Previous prostate radiation.
Prior hormonal therapy.
History of inflammatory bowel disease even if currently inactive or controlled on medication.
Prior systemic chemotherapy.
History of proximal urethral stricture requiring dilatation.
Current and continuing anticoagulation with Coumadin or equivalent.
Major medical or psychiatric illness

Accepts Healthy Volunteers

Sex

Male

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

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics