Health TrialsbyHealthPanel

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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAHS Cancer Control Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • radiotherapy

    Radiation

    External beam radiotherapy via stereotactic body radiotherapy (SBRT).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm 1/Stage 1: 5 weeksExperimental treatment 1 intervention
Group B: Arm 2/Stage 2: 3 weeksExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence

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

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 outcomes

1

Incidence

Cumulative incidence of acute CTCAE v6.0 ≥ grade 2 gastrointestinal (GI) toxicity

Time frame
Baseline 3 weeks 1 month 3 months 6 months 2 years
2

Incidence

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

Time frame
2 years
3

Incidence

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

Time frame
2 years
4

international index of erectile function (IIEF-5)

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
Baseline 3 weeks 1 month 3 months 6 months 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AHS Cancer Control Alberta

Lead sponsor

Source ClinicalTrials.gov
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