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Radiation

Focal Prostate Radiotherapy for Prostate Cancer (RAD1801 Trial)

N/A

Waitlist Available

Led By Andrew M McDonald, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Age ≥ 19 years

Clinical stage T1a-T2a by digital rectal exam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

RAD1801 Trial Summary

This trial is testing a new prostate cancer treatment that could offer fewer side effects than current options.

Who is the study for?

Men over 19 with early-stage prostate cancer (Gleason score 3+3 or 3+4, PSA <10 ng/mL) who have up to two small tumors visible on MRI. They should be relatively healthy (KPS >70%) and expected to live more than 10 years. Those with metal pelvic implants, prior pelvic surgery, significant medication use that can't be stopped, low platelets, or conditions preventing MRI are excluded.Check my eligibility

What is being tested?

The trial is testing a new way to treat prostate cancer using focal therapy. It involves placing an intra-urethral radiotransponder beacon during radiotherapy to target the cancer more precisely and potentially reduce long-term side effects.See study design

What are the potential side effects?

Potential side effects may include discomfort from the catheter placement, typical radiation-related symptoms like fatigue and skin irritation in the treated area, urinary issues due to inflammation from treatment, and possible bowel changes.

RAD1801 Trial Eligibility Criteria

Inclusion Criteria

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

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I am 19 years old or older.

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My prostate cancer is in an early stage, as determined by a physical exam.

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I am mostly able to care for myself and carry out daily activities.

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My prostate cancer has a Gleason score of 6 or 7.

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I have up to 2 prostate nodules seen on MRI, and they are small.

RAD1801 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Confirm the feasibility of focal prostate stereotactic body radiotherapy (SBRT) with real time guidance by intra-urethral radiotransponder beacons.

Secondary outcome measures

Assess early efficacy

Assess late toxicity

Assess quality of life

RAD1801 Trial Design

1Treatment groups

Experimental Treatment

Group I: Focal SBRT with intra-urethral radiotransponderExperimental Treatment1 Intervention

This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,278,024 Total Patients Enrolled

10 Trials studying Prostate Cancer

2,742 Patients Enrolled for Prostate Cancer

Andrew M McDonald, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03458234 — N/A

Prostate Cancer Research Study Groups: Focal SBRT with intra-urethral radiotransponder

Prostate Cancer Clinical Trial 2023: Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy Highlights & Side Effects. Trial Name: NCT03458234 — N/A

Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03458234 — N/A

Frequently Asked Questions

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

Does this experiment still have vacancies open for volunteers?

"Yes, the information on clinicaltrials.gov confirms that this medical research is currently accepting applications. It was initially posted on January 28th 2020 and modified most recently on August 20th 2022. The study requires 10 volunteers to be recruited from a single centre."

Answered by AI

How many participants have been recruited for this clinical trial so far?

"Affirmative. According to the clinicaltrials.gov database, this medical study, which was initially published on January 28th 2020, is currently recruiting participants. Specifically, 10 individuals need to be enrolled from one research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy

Andrew McDonald 2020. "RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03458234.