Jack Ady Cancer Centre
Lethbridge, Alberta, T1J 3H5, Canada
NCT Number: NCT07578519
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer.
For these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.
Trial opening soon.
Get Notified18 year and older
Male
Interventional
Phase 2
Lethbridge, Alberta, T1J 3H5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
External beam radiotherapy via stereotactic body radiotherapy (SBRT).
Time frame: Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years
Cumulative incidence of acute common terminology criteria for adverse events (CTCAE) v6.0 ≥ grade 2 genitourinary (GU) toxicity
Time frame: Baseline 3 weeks 1 month 3 months 6 months 2 years
Cumulative incidence of acute CTCAE v6.0 ≥ grade 2 gastrointestinal (GI) toxicity
Time frame: 2 years
Cumulative incidence of CTCAE v6.0 ≥ grade 2 GU toxicity at 2 years
Time frame: 2 years
Cumulative incidence of CTCAE v6.0 ≥ grade 2 GI toxicity at 2 years
Time frame: Baseline 3 weeks 1 month 3 months 6 months 2 years
IIEF-5 is a 5-item questionnaire (with a 1- 5 score for each item, 1 being the lowest or worst and 5 the highest/best) used to diagnose erectile disfunction.
Time frame: 1 month and 2 years post treatment
EPIC is a questionnaire designed to measure Quality of Life issues in patients with Prostate cancer. Overall GU domain is scored from 1 to 5 with 1 being "No problem" and 5 being "Big problem"
Time frame: 1 month and 2 years post treatment
EPIC GI is about bowel habits and abdominal pain and has an overall score of1 - 5 with 1 being "No problem" and 5 being "Big problem"
Time frame: 2 years post treatment
Proportion of patients with PSA <0.4ng/mL at 2 years post treatment
Time frame: 2 years post treatment
Absolute PSA nadir at 2 years post treatment (all therapy)
Time frame: treatment week 3
MRI based radiographic response of DIL at on treatment week 3
Time frame: 6 months post treatment
MRI based radiographic response at 6 months post treatment
Contact information is provided by the study sponsor or research team.
AHS Cancer Control Alberta
Other
DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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