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Brachytherapy

Radiation Therapy for Prostate Cancer

Q: What is the capacity of this clinical trial?

Affirmative, clinicaltrials.gov implies that this experiment is presently enrolling participants who were initially advertised for on July 17th 2019 and most recently updated October 6th 2022. The study requires 10 individuals from 3 distinct medical centres.

Q: Has Stereotactic Ablative Radiotherapy been sanctioned by the FDA?

Although there is no clinical data yet demonstrating Stereotactic Ablative Radiotherapy's efficacy, existing safety research has earned this treatment a score of 2.

Q: Are there any vacancies remaining in this trial for potential participants?

This clinical trial is still open for enrolment according to the information found on clinicaltrials.gov; it was initially posted in July of 2019 and recently updated in October, 2022.

Phase 2

Recruiting

Led By Lara Hathout

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not permitted

No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial is comparing two different types of radiation therapy to see which is better for treating localized prostate cancer.

Who is the study for?

Men recently diagnosed with localized prostate cancer, having low to intermediate risk (T1-T2 stage, Gleason score ≤7, PSA <15 ng/ml), and medically fit for brachytherapy. Prostate size must be ≤60 cc and IPSS ≤20. No prior treatments like surgery or chemotherapy for prostate cancer are allowed. Men must agree to not use hormonal therapy during the trial and commit to effective contraception.Check my eligibility

What is being tested?

This phase II trial compares two radiation therapies: high-dose rate brachytherapy (radiation via a seed inside the prostate) versus stereotactic ablative radiotherapy (external beam radiation in few large doses). The goal is to determine which treatment offers better quality of life as reported by patients themselves.See study design

What are the potential side effects?

Potential side effects include irritation of the bladder or bowel, urinary issues such as frequency or urgency, erectile dysfunction, fatigue, skin reactions in treated area, and rectal discomfort or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I am not currently on hormone therapy for cancer.

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I haven't taken any alpha reductase inhibitors in the last 2 weeks.

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My prostate cancer is in the early or intermediate stage.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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

Feasibility of comparing stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy (HDRB)

Secondary outcome measures

Changes in patient reported Health-Related Quality of life (HRQoL)

Changes in patient-reported sexual toxicity

Changes in patient-reported urinary toxicity

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (SABR)Experimental Treatment3 Interventions

Patients undergo SABR every other day for 5 treatments.

Group II: Arm I (HDR)Experimental Treatment3 Interventions

Patients undergo HDR.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High-Dose Rate Brachytherapy

2004

Completed Phase 2

~530

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,222 Total Patients Enrolled

14 Trials studying Prostate Cancer

1,044 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,844 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Lara HathoutPrincipal Investigator - Rutgers Cancer Institute of New Jersey

Rutgers Cancer Institute of New Jersey

Frequently Asked Questions

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

What is the capacity of this clinical trial?

"Affirmative, clinicaltrials.gov implies that this experiment is presently enrolling participants who were initially advertised for on July 17th 2019 and most recently updated October 6th 2022. The study requires 10 individuals from 3 distinct medical centres."

Answered by AI

Has Stereotactic Ablative Radiotherapy been sanctioned by the FDA?

"Although there is no clinical data yet demonstrating Stereotactic Ablative Radiotherapy's efficacy, existing safety research has earned this treatment a score of 2."

Answered by AI

Are there any vacancies remaining in this trial for potential participants?

"This clinical trial is still open for enrolment according to the information found on clinicaltrials.gov; it was initially posted in July of 2019 and recently updated in October, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer

Lara Hathout, MD, FRCPC 2019. "Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04253483.

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