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New treatment option for Prostate Adenocarcinoma
Official title INSPIRE: INnovative SABR for Prostate Cancer All IREland
ClinicalTrials.gov ID: NCT07552168
What this study is testing
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Gleason score ≤ 4+3
You likely can't join if
- Previous malignancy within the last 2 years (except basal cell carcinoma (BCC) or squamous carcinoma of the skin), or if previous malignancy is...
- 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...
- Life expectancy \<5 years.
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
- Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.
See the full eligibility criteria
- 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)
- Gleason score ≤ 4+3
- Clinical and/or MRI stage T1c-T3a, N0-X, M0-X
- PSA ≤ 30 ng/ml (within 60 days prior to registration / prior to starting androgen-deprivation therapy (ADT/hormone therapy) [PSA ≤ 15 ng/ml for patients on 5-alpha reductase inhibitors]
- Patients belonging to one of the following risk groups:
- Low risk - patients meeting all of the following criteria:
- Gleason ≤ 6
- Clinical stage T1c-T2a
- PSA \< 10 ng/ml (within 60 days prior to registration)
- Intermediate risk - patients meeting any of the following criteria, assuming no high-risk features apply:
- Gleason 7 (3+4 or 4+3)
- MRI stage T2b-T2c (N0, M0-X)
- PSA 10-20 ng/ml (within 60 days prior to registration)
- High risk - patients with tumours that meet a maximum of one of the following criteria:
- MRI stage T3a (N0, M0)
- PSA \>20 - ≤30 ng/ml (within 60 days prior to registration)
- 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.
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
- Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.
- Anticoagulation with warfarin/bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician. Note: Anti-platelet agents e.g. aspirin, clopidogrel and DOACs such as apixaban, rivaroxaban...
- Participation in another concurrent treatment protocol for prostate cancer (not including QoL, survivorship, exercise or registry studies).
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Leinster, Ireland
- Cork, Ireland
- Waterford, Ireland
- Belfast, Ulster, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Leinster, Ireland; Cork, Ireland; Waterford, Ireland; Belfast, Ulster, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.