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Not yet recruiting NCT07578519

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

Phase II Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: radiotherapy.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE

Overview

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.

Interventions

  • Radiation radiotherapy
    External beam radiotherapy via stereotactic body radiotherapy (SBRT).

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Incidence [Time frame: Baseline 3 weeks 1 month 3 months 6 months 2 years]
  • Incidence [Time frame: 2 years]
  • Incidence [Time frame: 2 years]
  • international index of erectile function (IIEF-5) [Time frame: Baseline 3 weeks 1 month 3 months 6 months 2 years]
  • expanded prostate cancer index composite (EPIC) [Time frame: 1 month and 2 years post treatment]
  • EPIC GI [Time frame: 1 month and 2 years post treatment]
  • PSA [Time frame: 2 years post treatment]
  • PSA nadir [Time frame: 2 years post treatment]
  • MRI [Time frame: treatment week 3]
  • MRI response [Time frame: 6 months post treatment]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the prostate
  • NCCN risk grouping of intermediate or high risk prostate cancer
  • Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent
  • Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist
  • Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI
  • Have not received prior pelvic radiotherapy
  • Life expectancy greater than 10 years
  • ECOG performance status <3
  • Eligible for SBRT to the prostate

Exclusion criteria

  • No identifiable lesion within the prostate on 3T MRI
  • Prior trans-urethral resection of the prostate
  • Non-adenocarcinoma histology
  • Meeting criteria for very high-risk risk or node positive prostate cancer
  • Active inflammatory bowel disease
  • Evidence of metastatic disease on CT or bone scan
  • Declined radiotherapy
  • Unlikely to be available for all follow-up appointments
  • Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy
  • Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible
  • Unable to understand or sign a study consent form after use of interpreter if required
  • Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma
  • Unable to tolerate or ineligible for mpMR imaging
  • Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigator interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Jack Ady Cancer Centre — Lethbridge

Identifiers

NCT: NCT07578519 · DAPAR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗