INSPIRE: INnovative SABR for Prostate Cancer All IREland
ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCancer Trials Ireland
About this trial
This is a Phase II, single arm, multi-centre, prospective clinical trial evaluating next generation Stereotactic Ablative Radiotherapy (SABR) for low, intermediate, and eligible high-risk prostate cancer. Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained prior to any study-related procedures
Males ≥ 18 years of age
ECOG performance status (PS) 0-2
Biopsy-proven prostate adenocarcinoma without neuro-endocrine differentiation (within 18 months prior to registration, unless on active surveillance and re-biopsy not clinically indicated)
Disqualifiers
Previous malignancy within the last 2 years (except basal cell carcinoma (BCC) or squamous carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
Prior pelvic radiotherapy
Any prior active treatment for prostate cancer (with the exception of ADT). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
Life expectancy <5 years.
Trial design
Design model
Single group
Treatments tested in this trial
Next generation Stereotactic Ablative Radiotherapy (SABR)
RadiationTreatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs).
Treatment groups
136 Participants
are divided into 1 treatment groupGroup A: Next generation Stereotactic Ablative Radiotherapy (SABR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Late GU toxicity
Rate of ≥ Grade 2 version 5 (v5) NCI CTCAE late GU toxicity in next-generation prostate SABR at 2 years.
Time frame
2 years after last fractionSecondary outcomes
1
Acute GU Toxicity
Acute Grade ≥ 2 GU toxicity ≤12 weeks, using v5 NCI CTCAE
Time frame
≤12 weeks after last fraction2
Acute GI Toxicity
Acute Grade ≥ 2 GI toxicity ≤12 weeks, using v5 NCI CTCAE
Time frame
≤12 weeks after last fraction3
Late GU toxicity at 5 years
Late Grade ≥ 2 GU toxicity at 5 years, using v5 NCI CTCAE
Time frame
5 years after last fraction4
Late GI toxicity at 5 years
Late Grade ≥ 2 GI toxicity at 5 years, using v5 NCI CTCAE
Time frame
5 years after last fractionOther outcomes
1
Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via Penile Shortening and well being questionnaire (PSW E9).
PSW E9 will be reported at baseline, 6 months and 2 years post treatment. PSW E9 is a 9 item questionnaire using a Likert scale 0-4 where higher scores indicate lower satisfaction.
Time frame
Baseline, 6 months and 2 years post treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov