Radiation Treatment of the Prostate That is Specially Adjusted for Each Person

Sponsor
AHS Cancer Control Alberta
Study ID
NCT07578519
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • radiotherapy — RADIATION
    External beam radiotherapy via stereotactic body radiotherapy (SBRT).

Study Details

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.

Key Dates

First listed
May 11, 2026
Start date
Aug 26, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1/Stage 1: 5 weeks
    The first group of 25 patients enrolled will receive 5 fractions of radiotherapy to their prostate with or without radiotherapy to their pelvic lymph nodes and an MRI midway through the treatment to assess the response of disease.
  • Experimental: Arm 2/Stage 2: 3 weeks
    The second group of 25 patients enrolled in this study will receive a single fraction of radiation to the prostate +/- pelvis with extra radiation to any nodule(s)/tumors in the prostate identified on MR. They will then have a second MR after 3 weeks and based on that MR a second fraction of radiation to the prostate +/- pelvis will be delivered.

Primary Outcome Measure

Incidence [ 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 ]

Central Contacts

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