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Proton Beam Therapy

High-Dose Radiotherapy for Prostate Cancer (PROSINT Trial)

Phase 2
Waitlist Available
Led By Madhur Garg, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gleason score 7
Histologic confirmation of adenocarcinoma of the prostate by biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants should be followed continuously for the duration of 5 years
Awards & highlights

PROSINT Trial Summary

This trial is evaluating treatment outcomes for prostate cancer patients classified as intermediate risk, comparing two different regimens of external beam radiotherapy.

Who is the study for?
Men over 50 with intermediate-risk prostate cancer, which means a Gleason score of 7, PSA levels between >10 and ≤20 ng/mL, and no evidence of spread beyond the prostate. They must have good performance status (able to carry out daily activities), a prostate size ≤100 grams, and an International Prostate Symptom Score ≤15.Check my eligibility
What is being tested?
The study is testing two high-dose radiation treatments using IGRT technology for men with intermediate-risk prostate cancer. One group will receive a single dose of 24 Gy; another will get five doses at 9 Gy each. The trial aims to compare outcomes and side effects like urinary, rectal, and sexual function.See study design
What are the potential side effects?
Potential side effects include issues related to urinary functions such as difficulty urinating or increased frequency, rectal discomfort or bleeding, changes in sexual function including erectile dysfunction. Acute toxicity may involve skin reactions in the treated area.

PROSINT Trial 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 of 7.
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My prostate cancer was confirmed by a biopsy.
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I can take care of myself and am up and about more than half of the day.
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I am 50 years old or older.
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My breast cancer is in an early stage according to my MRI results.
Select...
My prostate is estimated to be 100 grams or less in size.
Select...
My cancer has not spread to other parts of my body according to recent tests.
Select...
My prostate symptoms are mild to moderate.

PROSINT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants should be followed continuously for the duration of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants should be followed continuously for the duration of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0
Secondary outcome measures
Prostate-Specific Antigen
Pathological response based on biopsy at 24 months post-treatment
Quality of life assessment based on International Index of Erectile Function (IIEF)
+1 more

PROSINT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IGRT 24 Gy single doseExperimental Treatment4 Interventions
single fraction IGRT at a prescription dose of 24 Gy
Group II: IGRT 45 Gy in 5 fractions of 9 GyActive Control4 Interventions
Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IGRT 45 Gy in 5 fractions of 9 Gy
2015
N/A
~30
IGRT 24 Gy single dose
2015
N/A
~30
Dexamethasone
FDA approved
Tamsulosin
FDA approved

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,078 Total Patients Enrolled
2 Trials studying Prostate Cancer
59 Patients Enrolled for Prostate Cancer
Madhur Garg, MDPrincipal InvestigatorAssociate Clinical Director
3 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

IGRT 24 Gy single dose (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04147806 — Phase 2
Prostate Cancer Research Study Groups: IGRT 45 Gy in 5 fractions of 9 Gy, IGRT 24 Gy single dose
Prostate Cancer Clinical Trial 2023: IGRT 24 Gy single dose Highlights & Side Effects. Trial Name: NCT04147806 — Phase 2
IGRT 24 Gy single dose (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04147806 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
2016. "A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04147806.
All > Prostate Cancer New York
~6 spots leftby May 2026
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