NCT00951535Active, not recruitingPhase 2
A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
This is a prospective, phase II non-randomised controlled clinical study. Dose escalation will be implemented using 1.8 Gy increments from baseline 75.6 Gy. Patients' RT prescription may be escalated up to max 81 Gy once dose volume constraints are adhered to. All patients will be treated using the participating institution's standard rectal preparation protocol, bladder-filling protocol and appropriate immobilisation device(s). Cone beam CT on-treatment imaging is recommended for this study. However, the use of individual institutional imaging equipment and techniques is permitted. Acute GU/GI toxicities will be assessed weekly during treatment. GU/GI toxicities will also be assessed 2 months post RT, 8 months post RT and 6 monthly thereafter to year nine and in line with the participating institution's standard routine follow-up (FU) thereafter. Translational sub-studies (optional), only apply to patients who are consented prior to commencement of hormone therapy at centres participating in the translational sub-study. Patients at centres participating in the translational sub-studies will be given the option of participating in sub-study 1 (Proteomic Analysis), sub-study 2 (Raman spectroscopic analysis), or both (sample collection will not be mandatory).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 251 (actual)
- First submitted
- 1 Aug 2009
- Start date
- 20 Jul 2009
- Primary completion date
- May 2026
- Lead sponsor
- Cancer Trials Ireland
- Diseases
- Prostate cancer
- NCT number
- NCT00951535
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 251
- From 20 Jul 2009 to the primary completion date, May 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous RT to the pelvic region
- The patient has previously received a full course of hormonal treatment for his prostate cancer
Other illness
- The patient has or has had other malignancies within the last 5 years (non-melanoma skin cancer is permitted)
Lab values
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research/ medical team that the patient may not be able to comply with the protocol
Other
- The patient has nodal involvement or it is decided to electively treat pelvic lymph nodes
- The patient has had a bilateral orchidectomy
- Patients who have had a prostatectomy
- The presence of hip prostheses
Who the study is looking for
- Patients undergoing a radical course of RT for high-risk disease (defined according to the National Comprehensive Cancer Network Practice Guidelines in Oncology v.1 as one or more of the NCCN high risk criteria \> or equal to T3, \> or equal to Gleason 8, PSA \> 20ng/ml)
- Only patients requiring neo-adjuvant / adjuvant hormonal therapy will be included in this study
- Absence of distant metastases as demonstrated by history and physical examination, FBC, screening profile including liver function tests, PSA and bone scan
- All patients must have an MRI/CT of the prostate and pelvis to investigate the nodal status and precise T-stage. This MRI/CT scan must be performed prior to commencement of hormonal therapy. Suspicious nodes need to be histologically proven to be benign before the patient can be included in the study). M0 on staging.
- No previous surgery for urinary conditions except TURP or TRUS
- KPS \> or equal to 60
- Age \>18 years
- Provision of written informed consent in line with ICH-GCP guidelines
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
| SLRON St James's Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| SLRON St Luke's Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| SLRON, Beaumont Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Beacon Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.