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Proton Beam Therapy

MRI-Guided Prostate Boosts for Prostate Cancer (BLaStM Trial)

N/A

Recruiting

Led By Alan Pollack, MD, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Gleason score 6-10

No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.25 years (post-treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, more effective radiation treatment for prostate cancer. The hope is that it will improve cancer control and quality of life by reducing damage to nearby organs.

Who is the study for?

Men aged 35-85 with confirmed prostate cancer (adenocarcinoma), T1-T3 stage, Gleason score 6-10, and PSA ≤100 ng/mL. No metastasis or previous radical prostate surgery/radiotherapy. Androgen deprivation therapy is allowed if decided before joining. Participants must be able to consent and willing to complete quality of life assessments.

What is being tested?

The study tests adding a high dose radiation treatment targeting MRI-defined high-risk tumor areas in the prostate, on top of standard radiation therapy, aiming to control cancer while sparing nearby organs from excess radiation.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, fatigue, urinary issues like increased frequency or urgency, bowel changes such as diarrhea or rectal bleeding, and sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has a Gleason score between 6 and 10.

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I have not had a complete prostate removal surgery.

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I am between 35 and 85 years old.

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My prostate cancer is confirmed by biopsy.

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My cancer is in an early to mid-stage according to a physical exam.

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My cancer has not spread to other parts of my body according to tests.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of disorders related to lymphocyte proliferation.

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I have a history of cancer.

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I do not have any active cancer except for non-spreading skin cancer or early chronic lymphocytic leukemia.

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I have had my prostate completely removed.

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I am younger than 35 or older than 85 years old.

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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.25 years (post-treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5.25 years (post-treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.25 years (post-treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Early Prostate Tumor Response (EPTR)

Secondary study objectives

Change in CTC Levels

Change in gene/biomarker expression

Correlation between EPTR and Changes in serial post-RT MRIs

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: LEAD RT GroupExperimental Treatment1 Intervention

Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Group II: HEIGHT RT GroupExperimental Treatment1 Intervention

Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

955 Previous Clinical Trials

428,689 Total Patients Enrolled

19 Trials studying Prostate Cancer

4,133 Patients Enrolled for Prostate Cancer

Alan Pollack, MD, PhD5.02 ReviewsPrincipal Investigator - University of Miami

University of Miami

5 Previous Clinical Trials

2,435 Total Patients Enrolled

5 Trials studying Prostate Cancer

2,435 Patients Enrolled for Prostate Cancer

5Patient Review

Dr. Pollack is a highly skilled researcher who will go above and beyond to ensure your needs are met. He's compassionate and competent — a rare find in the medical field today.