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Radiation Therapy

Hypofractionated Radiation Therapy for Prostate Cancer

Q: Has the FDA approved Hypofractionated, image-guided, intensity-modulated external beam radiation?

Hypofractionated, image-guided, intensity-modulated external beam radiation is still in its earliest testing stages so it receives a safety score of 1. This rating reflects the limited data that exists to support both efficacy and safety at this time.

Q: Are there still opportunities for participants to join this clinical trial?

As indicated on clinicaltrials.gov, recruitment for this trial has ceased; it was initially posted in May 2009 and last updated on June 15th 2022. However, there are 2031 other trials currently inviting participants to join their study.

Q: Is there an age restriction on participation in this medical test?

The eligibility criteria to participate in this research stipulates that the age range of participants should be between 18 and 85. There are currently 79 studies recruiting individuals younger than 18, while 2024 trials seek those aged 65 or older.

Q: How many venues are hosting this trial?

Memorial Sloan Kettering <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Centers in Uniondale, Harrison and Sleepy Hollow are recruiting patients for this study. Additionally, 4 other sites have opened their doors to participants as well.

Q: Is there a possibility for me to partake in this medical experiment?

This clinical trial is recruiting 120 individuals between 18 to 85 years old that have been diagnosed with <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>. In order for them to qualify, they must meet the following conditions: PSA levels of 10 ng/ml or lower; Low and intermediate risk groups determined by NCCN guidelines; Gleason score of 6 and Clinical Stage T2a or below; men whose Prostate Specific Antigen (PSA) level falls between 10-20 ng/ml, who have a Gleason Score 7,or are in a Clinical stage T2b/T2c; age minimum requirement of 18, Karnofsky Performance Scale higher than

Phase 1

Waitlist Available

Led By Michael Zelefsky, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low risk prostate cancer patients: PSA < or = to 10 ng/ml, Gleason score = 6, Clinical Stage < or = to T2a

Intermediate risk prostate cancer patients: PSA 10-20 ng/ml, Gleason score = 7, Clinical stage T2b/T2c

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, & 6 months (+/- 4 weeks) months 6 - 36 every 6 months (+/- 4 weeks)

Awards & highlights

Study Summary

This trial is testing if it's safe to give a higher dose of radiation during each treatment day for cancer, which would reduce the number of treatments from 48 to 5.

Who is the study for?

Men aged 18 or older with low to intermediate risk prostate cancer, defined by specific PSA levels, Gleason scores, and clinical stages. They must have a good performance status (able to carry out daily activities), no severe urinary symptoms, a prostate size ≤60 cc, and no evidence of advanced disease on MRI/CT scans.Check my eligibility

What is being tested?

The trial is testing an advanced form of radiation therapy for prostate cancer called ultra-hypofractionated IG-IMRT. It involves fewer treatment sessions (5 over two weeks) with higher doses each time compared to the standard 45-48 treatments.See study design

What are the potential side effects?

Potential side effects may include skin reactions in the treated area, fatigue, urinary issues such as increased frequency or discomfort during urination, bowel changes like diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is low risk with a PSA of 10 or less, Gleason score of 6, and stage T2a or lower.

Select...

My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.

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I am 18 years old or older.

Select...

I am mostly able to care for myself.

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My prostate symptoms are mild.

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My prostate is 60 cc or smaller.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, & 6 months (+/- 4 weeks) months 6 - 36 every 6 months (+/- 4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, & 6 months (+/- 4 weeks) months 6 - 36 every 6 months (+/- 4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, & 6 months (+/- 4 weeks) months 6 - 36 every 6 months (+/- 4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.

Secondary outcome measures

Evaluate pathologic response rates at 24-36 months via repeat biopsy.

Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.

Evaluate the effect of treatment on sexual function.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RadiationExperimental Treatment1 Intervention

Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,200 Total Patients Enrolled

132 Trials studying Prostate Cancer

51,392 Patients Enrolled for Prostate Cancer

Montefiore Medical CenterOTHER

445 Previous Clinical Trials

582,485 Total Patients Enrolled

2 Trials studying Prostate Cancer

172 Patients Enrolled for Prostate Cancer

Michael Zelefsky, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

11 Previous Clinical Trials

922 Total Patients Enrolled

8 Trials studying Prostate Cancer

615 Patients Enrolled for Prostate Cancer

Media Library

$Hypofractionated, image-guided, intensity-modulated external beam radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00911118 — Phase 1$

Prostate Cancer Research Study Groups: Radiation

$Prostate Cancer Clinical Trial 2023: Hypofractionated, image-guided, intensity-modulated external beam radiation Highlights & Side Effects. Trial Name: NCT00911118 — Phase 1$

$Hypofractionated, image-guided, intensity-modulated external beam radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00911118 — Phase 1$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved Hypofractionated, image-guided, intensity-modulated external beam radiation?

"Hypofractionated, image-guided, intensity-modulated external beam radiation is still in its earliest testing stages so it receives a safety score of 1. This rating reflects the limited data that exists to support both efficacy and safety at this time."

Answered by AI

Are there still opportunities for participants to join this clinical trial?

"As indicated on clinicaltrials.gov, recruitment for this trial has ceased; it was initially posted in May 2009 and last updated on June 15th 2022. However, there are 2031 other trials currently inviting participants to join their study."

Answered by AI

Is there an age restriction on participation in this medical test?

"The eligibility criteria to participate in this research stipulates that the age range of participants should be between 18 and 85. There are currently 79 studies recruiting individuals younger than 18, while 2024 trials seek those aged 65 or older."

Answered by AI

How many venues are hosting this trial?

"Memorial Sloan Kettering Cancer Centers in Uniondale, Harrison and Sleepy Hollow are recruiting patients for this study. Additionally, 4 other sites have opened their doors to participants as well."

Answered by AI

Is there a possibility for me to partake in this medical experiment?

"This clinical trial is recruiting 120 individuals between 18 to 85 years old that have been diagnosed with prostate cancer. In order for them to qualify, they must meet the following conditions: PSA levels of 10 ng/ml or lower; Low and intermediate risk groups determined by NCCN guidelines; Gleason score of 6 and Clinical Stage T2a or below; men whose Prostate Specific Antigen (PSA) level falls between 10-20 ng/ml, who have a Gleason Score 7,or are in a Clinical stage T2b/T2c; age minimum requirement of 18, Karnofsky Performance Scale higher than"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

2009. "Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00911118.

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