Status:
UNKNOWN
A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Primary Objective: To determine if dose escalated IMRT for high risk localised prostate cancer can provide PSA relapse free survival similar to that reported by Memorial Sloan Kettering (Alicikus et ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Previous RT to the pelvic region
- The patient has nodal involvement or it is decided to electively treat pelvic lymph nodes
- The patient has had a bilateral orchidectomy
- The patient has previously received a full course of hormonal treatment for his prostate cancer
- The patient has or has had other malignancies within the last 5 years (non-melanoma skin cancer is permitted)
- 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
- Patients who have had a prostatectomy
- The presence of hip prostheses
Key Trial Info
Start Date :
July 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00951535
Start Date
July 20 2009
End Date
October 1 2025
Last Update
April 6 2023
Active Locations (5)
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1
Cork University Hospital
Cork, Ireland
2
SLRON St Luke's Hospital
Dublin, Ireland, 6
3
Beacon Hospital
Dublin, Ireland
4
SLRON St James's Hospital
Dublin, Ireland