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Radiation Therapy

MRI-Guided Prostate SBRT for Prostate Cancer (ARGOS/CLIMBER Trial)

N/A
Recruiting
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years of age
Histologically confirmed carcinoma of the prostate
Must not have
Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat prostate cancer that is more precise and has fewer side effects.

Who is the study for?
Men over 18 with high intermediate-risk, high-risk, or very high-risk prostate cancer that hasn't spread beyond the pelvis. They must have no history of prior prostate cancer treatments (except for certain medications), be able to undergo MRI and PSMA PET scans without contraindications like incompatible implants, and not have severe urinary problems or conditions preventing radiotherapy.
What is being tested?
The trial is testing a targeted radiation therapy called SBRT guided by PSMA PET scans and mpMRI images in men with specific risk levels of prostate cancer. It involves fusing these images with CT simulations for precise tumor targeting, using fiducial markers for motion management during treatment, and escalating doses to identified targets while protecting surrounding organs.
What are the potential side effects?
Potential side effects may include irritation or damage to nearby organs such as the bladder and rectum due to radiation exposure, changes in urinary function, fatigue from treatment sessions, skin reactions at the site of radiation application, and possible allergic reactions to imaging agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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My prostate cancer has been confirmed by a tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo intense prostate radiotherapy due to certain health conditions like connective tissue disease.
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I have had prostate cancer treatment, but not hormone therapy before joining.
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My cancer has spread beyond the pelvic area.
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I have a bleeding disorder.
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I do not have clinical T4 disease.
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I am allergic or cannot tolerate the PSMA PET agent PSMA 1007.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-month Toxicity
6-week Toxicity
Secondary study objectives
Disease Free Survival
Quality of Life

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: Men with high intermediate to very high risk protstate cancerExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,883 Total Patients Enrolled
15 Trials studying Prostate Cancer
595 Patients Enrolled for Prostate Cancer

Media Library

PSMA MRI Guided Prostate SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05269550 — N/A
Prostate Cancer Research Study Groups: Men with high intermediate to very high risk protstate cancer
Prostate Cancer Clinical Trial 2023: PSMA MRI Guided Prostate SBRT Highlights & Side Effects. Trial Name: NCT05269550 — N/A
PSMA MRI Guided Prostate SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269550 — N/A
~14 spots leftby Nov 2025
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