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Proton Beam Therapy

Image-guided Radiotherapy for Prostate Cancer (MIDAS-Prostate Trial)

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Biochemical relapse with local or regional recurrence proven on PSMA PET.

Men older than 18 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 5-year follow-up

Awards & highlights

MIDAS-Prostate Trial Summary

This trial is testing a new way to do radiation therapy for prostate cancer that has come back after surgery. They will use a special scan to find where the cancer is and give a high dose of radiation to that area while sparing the healthy tissue.

Who is the study for?

This trial is for men over 18 with a history of prostate cancer, who've had surgery but are now experiencing a relapse confirmed by PSMA PET scans. They should be relatively healthy and active (ECOG 0-1) and have no more than five positive nodes on their scan. Men with contraindications to radiation, distant metastasis, chronic pelvic inflammation, or previous pelvic radiation can't join.Check my eligibility

What is being tested?

The study tests if adjusting the radiation dose based on molecular imaging can help in treating prostate cancer that has come back after surgery. Participants will get higher doses at the recurrence site and lower doses elsewhere. The effects will be monitored for up to five years.See study design

What are the potential side effects?

While not specified here, typical side effects of image-guided radiotherapy may include skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding.

MIDAS-Prostate Trial Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned and is shown on a PSMA PET scan.

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I am a man over 18 years old.

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I have had surgery to remove my prostate.

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My initial cancer diagnosis was adenocarcinoma of the prostate.

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I am fully active or can carry out light work.

MIDAS-Prostate Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5-year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 5-year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Grade ≥2 Toxicity for GU

Secondary outcome measures

Biochemical Failure Free Survival

Patient-reported quality-of-life assessed by EPIC-26

MIDAS-Prostate Trial Design

1Treatment groups

Experimental Treatment

Group I: Molecular Imaging Informed Radiation Dose Escalation and De-escalationExperimental Treatment1 Intervention

Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,120 Total Patients Enrolled

63 Trials studying Prostate Cancer

15,340 Patients Enrolled for Prostate Cancer

Media Library

Image-guided Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05328505 — N/A

Prostate Cancer Research Study Groups: Molecular Imaging Informed Radiation Dose Escalation and De-escalation

Prostate Cancer Clinical Trial 2023: Image-guided Radiotherapy Highlights & Side Effects. Trial Name: NCT05328505 — N/A

Image-guided Radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328505 — N/A

Frequently Asked Questions

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

Is there currently availability for participants in this trial?

"The details hosted on clinicaltrials.gov suggest that this trial is still open for patient recruitment, having been first published November 1st 2022 and amended most recently on October 6th 2022."

Answered by AI

How many volunteers will be included in this research initiative?

"Affirmative. According to the clinicaltrials.gov, this scientific exploration is still recruiting members of the public - having been posted on November 1st 2022 and revised recently in October 6th 2022. 60 participants are necessary for its success from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

2022. "Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05328505.