Recruiting
Phase 2

Radiotherapy Treatments

Sponsor:

AHS Cancer Control Alberta

Code:

NCT07578519

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

radiotherapy

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT07578519

Start date

Aug 26, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2032

Anticipated

Primary completion date

Jun, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

radiotherapy

External beam radiotherapy via stereotactic body radiotherapy (SBRT).

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 and Locations

Central contacts

Charlie Kirkby

403-388-6872Charles.Kirkby@cancercarealberta.ca

Asongna Folefoc

Asongna.Folefoc@cancercarealberta.ca

Locations

Jack Ady Cancer Centre

Recruiting

Lethbridge, Alberta, Canada, T1J 3H5

Contacts

Charlie Kirkby

403-388-6872Charles.Kirkby@cancercarealberta.ca

Kevin Martell

Kevin.Martell@CancerCareAlberta.ca

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Radiotherapy
  • prostate cancer
  • treatment
  • radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2026-09-03.