Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084552
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2004-06-10
Brief Title:
Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-02
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 Intensity-modulated radiation therapy radiation directed at the tumor more precisely than in standard radiation therapy may reduce damage to healthy tissue near the tumor It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction
PURPOSE This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer
PURPOSE This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue
Secondary
Compare biochemical freedom from failure rates as a measure of prostate cancer control in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens
OUTLINE This is a randomized single-blind study Patients are stratified according to age 65 vs 65 prescription radiotherapy dose 74 Gy vs 76 Gy and frequency of erection during sexual activity within the past 4 weeks a few times vs sometimes vs most times to always Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conventional intensity-modulated radiotherapy IMRT once daily 5 days a week for approximately 75 weeks
Arm II Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 75 weeks
Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis
Quality of life is assessed at baseline at 6 and 12 months and then annually for 4 years
Patients are followed at 3 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study within 25 years
Primary
Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue
Secondary
Compare biochemical freedom from failure rates as a measure of prostate cancer control in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens
OUTLINE This is a randomized single-blind study Patients are stratified according to age 65 vs 65 prescription radiotherapy dose 74 Gy vs 76 Gy and frequency of erection during sexual activity within the past 4 weeks a few times vs sometimes vs most times to always Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conventional intensity-modulated radiotherapy IMRT once daily 5 days a week for approximately 75 weeks
Arm II Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 75 weeks
Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis
Quality of life is assessed at baseline at 6 and 12 months and then annually for 4 years
Patients are followed at 3 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study within 25 years
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 |
|---|---|---|---|
| CDR0000365458 | None | None | None |