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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.
Must not have
Presence of para-aortic lymph nodes or distant metastasis.
Previous radiation treatment within the pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5-year follow-up
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to the lymph nodes near my aorta or to distant parts of my body.
Select...
I have had radiation treatment in my pelvic area.
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I cannot undergo radiation therapy due to health reasons.
Select...
I have a long-term infection in my pelvic area.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade ≥2 Toxicity for GU
Secondary study objectives
Biochemical Failure Free Survival
Patient-reported quality-of-life assessed by EPIC-26

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,224 Total Patients Enrolled
65 Trials studying Prostate Cancer
15,512 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
~50 spots leftby Aug 2028
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