Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002703
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Sponsor:
Proton Radiation Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high energy x-rays to damage tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES I Determine whether high-dose radiotherapy using conformal photons with a proton boost produces a 20 increase in the proportion of Stage III prostate cancer free from local failure and biochemical relapse at 5 years when compared to results of conventional-dose radiotherapy II Determine whether high-dose radiotherapy produces a 33 reduction in the cumulative incidence of a rising PSA second hormone failure following hormone therapy given at the time of first PSAclinical failure when compared with conventional-dose radiotherapy IV Assess the relative rectal bladder and sexual morbidity of conformal photon doses of 702 and 792 Gy in these patients V Collect in a prospective manner paraffin biopsy blocks for subsequent analysis of emerging molecular pathologic predictors of outcome in three patients
OUTLINE Randomized study Arm I Radiotherapy Boost to the prostate using high-LET protons followed by irradiation of the prostate periprostatic tissues and seminal vesicles using conformal photons with energies greater than 6 MV Conventional dose Arm II Radiotherapy As in Arm I High dose
PROJECTED ACCRUAL There will be 390 patients accrued into this study over 3 years An additional 35 years will be required for follow-up
OUTLINE Randomized study Arm I Radiotherapy Boost to the prostate using high-LET protons followed by irradiation of the prostate periprostatic tissues and seminal vesicles using conformal photons with energies greater than 6 MV Conventional dose Arm II Radiotherapy As in Arm I High dose
PROJECTED ACCRUAL There will be 390 patients accrued into this study over 3 years An additional 35 years will be required for follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PROG-9509 | None | None | None |