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NCT Number: NCT07578519

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

External beam radiotherapy via stereotactic body radiotherapy (SBRT).

Primary outcomes

  1. 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

    Cumulative incidence of acute common terminology criteria for adverse events (CTCAE) v6.0 ≥ grade 2 genitourinary (GU) toxicity

Secondary outcomes

  1. Incidence

    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

  2. Incidence

    Time frame: 2 years

    Cumulative incidence of CTCAE v6.0 ≥ grade 2 GU toxicity at 2 years

  3. Incidence

    Time frame: 2 years

    Cumulative incidence of CTCAE v6.0 ≥ grade 2 GI toxicity at 2 years

  4. international index of erectile function (IIEF-5)

    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.

  5. expanded prostate cancer index composite (EPIC)

    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"

  6. EPIC GI

    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"

  7. PSA

    Time frame: 2 years post treatment

    Proportion of patients with PSA <0.4ng/mL at 2 years post treatment

  8. PSA nadir

    Time frame: 2 years post treatment

    Absolute PSA nadir at 2 years post treatment (all therapy)

  9. MRI

    Time frame: treatment week 3

    MRI based radiographic response of DIL at on treatment week 3

  10. MRI response

    Time frame: 6 months post treatment

    MRI based radiographic response at 6 months post treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Asongna Folefoc

CONTACT

[email protected]

Charlie Kirkby

CONTACT

[email protected]

403-388-6872

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Official study title

DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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