Hypofractionated Radiation Therapy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Maryland Proton Treatment Center, Baltimore, MDProstate Cancer+1 MoreHypofractionated Radiation Therapy - Radiation
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is testing if it is safe to give three different schedules of radiation therapy to the pelvis and prostate to see if it kills cancer cells while not harming normal cells too much.

Eligible Conditions
  • Prostate Cancer
  • Prostate Adenocarcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during Year 2

Year 2
Patient Reported Outcomes (PROs) related to urinary and bowel function
Patient Reported Outcomes (PROs) related to urinary function
Year 2
Evaluate the duration of biochemical progression-free survival
Year 2
Acute Coryza
Day 90
Dose volume histogram (DVH) parameters
HypoFx RT schedule that results in <33% acute dose-limiting toxicity with accelerated, HypoFx pelvic nodal RT

Trial Safety

Trial Design

3 Treatment Groups

Dose Level 3
1 of 3
Dose Level 1
1 of 3
Dose Level 2
1 of 3

Experimental Treatment

18 Total Participants · 3 Treatment Groups

Primary Treatment: Hypofractionated Radiation Therapy · No Placebo Group · Phase 1

Dose Level 3
Radiation
Experimental Group · 1 Intervention: Hypofractionated Radiation Therapy · Intervention Types: Radiation
Dose Level 1
Radiation
Experimental Group · 1 Intervention: Hypofractionated Radiation Therapy · Intervention Types: Radiation
Dose Level 2
Radiation
Experimental Group · 1 Intervention: Hypofractionated Radiation Therapy · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month after completion of treatment, every 3 months for year 1, and every 6 months during year 2

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
617 Previous Clinical Trials
355,980 Total Patients Enrolled
11 Trials studying Prostate Cancer
493 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

To what magnitude is the current participant pool of this trial?

"Affirmative, clinicaltrials.gov records indicate that this trial has been actively recruiting since November 19th 2020 and is currently in search of 18 patients to be enrolled at 1 medical centre." - Anonymous Online Contributor

Unverified Answer

Is Hypofractionated Radiation Therapy a reliable approach for ensuring safety?

"As this is an initial stage trial, the safety of Hypofractionated Radiation Therapy was scored a 1 due to limited clinical data indicating its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Is the recruitment process for this research endeavor still ongoing?

"Per clinicaltrials.gov, the researchers are actively seeking participants for this experiment, which was posted on November 19th 2020 and most recently updated April 26th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.