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Proton Beam Therapy

High-Dose Radiation Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Victoria Brennan, MBBCH BAO

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

Age ≥ 18

Karnofsky Performance Status (KPS) ≥ 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing whether giving a higher dose of radiation to the main tumor will cure prostate cancer or prevent it from coming back.

Who is the study for?

Men over 18 with intermediate-risk prostate cancer can join this trial. They should have a PSA level of 10-20 ng/ml, Gleason score equal to 7, and clinical stage T2b/T2c. Their prostate size must be ≤80 cc with a visible lesion on MRI that's at least 0.5 cm. They need to be in good health (KPS ≥80), have mild urinary symptoms (IPSS ≤15), and meet specific MRI criteria without severe claustrophobia or metal implants that affect the scan.Check my eligibility

What is being tested?

This study tests if giving a high 'boost' dose of radiation directly to the main tumor along with standard doses to the rest of the prostate is more effective in treating intermediate-risk prostate cancer than current methods. The goal is longer-lasting prevention of cancer return with minimal side effects.See study design

What are the potential side effects?

Potential side effects from high-dose radiation may include skin changes, fatigue, frequent urination, painful urination, rectal bleeding or irritation, erectile dysfunction, and other urinary or bowel issues.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can carry out normal activities with minimal symptoms.

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My prostate is 80 cc or smaller.

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My prostate cancer is at an intermediate stage with specific PSA, Gleason score, or clinical stage.

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I meet all MRI requirements and agree to complete the MRI form.

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My prostate symptoms are mild.

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My prostate cancer shows one main tumor larger than 0.5 cm and at most one small tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Comparison of pretreatment biopsy with post-treatment biopsy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prostate cancer patientsExperimental Treatment1 Intervention

Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: PSA 10-20 ng/ml or Gleason score = 7 Clinical stage T2b/T2c

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,229 Total Patients Enrolled

132 Trials studying Prostate Cancer

51,421 Patients Enrolled for Prostate Cancer

Victoria Brennan, MBBCH BAOPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

MRI-guided High-dose Radiation Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04997018 — Phase 2

Prostate Cancer Research Study Groups: Prostate cancer patients

Prostate Cancer Clinical Trial 2023: MRI-guided High-dose Radiation Therapy Highlights & Side Effects. Trial Name: NCT04997018 — Phase 2

MRI-guided High-dose Radiation Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997018 — Phase 2

Frequently Asked Questions

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

Are patients being signed up for this experiment right now?

"That is correct, according to the clinicaltrials.gov website this study is still looking for participants. The trial was originally posted on 8/4/2021 and was last edited on 8/29/2022. They are hoping to enroll 91 people at 7 different locations."

Answered by AI

How many people can join this trial at most?

"That is correct, the online clinicaltrials.gov registry has this study listed as currently recruiting patients. The trial was posted on 8/4/2021 and was last updated nearly a year later on 8/29/2022. Currently, 91 people are needed to complete the study at 7 sites."

Answered by AI

At how many distinct locations is this research being conducted?

"Right now, this trial is recruiting from 7 clinical sites. 4 of these are in New york (Basking Ridge, Middletown and New York) with the other 3 located elsewhere. For your convenience, pick a location near to reduce travel time if you decide to participate."

Answered by AI

Are there any long-term risks associated with radiation therapy?

"While there is some evidence of safety, as this therapeutic intervention is in Phase 2 clinical trials, there is no data yet to support its efficacy. Therefore, it received a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

2021. "A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04997018.

All > Prostate Cancer