Prostate CancerPhase 2NCT00951535
A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17
A Phase 2 study testing questionnaire administration, quality-of-life assessment and image-guided radiation therapy in people with Prostate Cancer, run by Cancer Trials Ireland at 5 sites in Ireland.
Trial 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 up to max 81 Gy once dose volume constraints are adhered to. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- questionnaire administration, quality-of-life assessment and image-guided radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 5 sitesIreland
- Study dates
- 20 Jul 2009to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
Cork University Hospital
Cork
SLRON St Luke's Hospital
Dublin, 6
Beacon Hospital
Dublin
SLRON St James's Hospital
Dublin
SLRON, Beaumont Hospital
Dublin
About this study
Official title: A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer
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).
Read more
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).
Read the 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 al 2011).
Sub-Study 1 (Proteomic Analysis):
To use proteomic analysis of sequential blood and urine samples to detect changes in profiles that may predict outcome and identify prognostic biochemical markers of early disease progression and/ or toxicity. The unique molecular signatures may also allow the identification of targets for therapeutic intervention.
To undertake, where possible, other biochemical analyses including mRNA, miRNA and metabolite profiling.
Sub-Study 2 (Raman spectroscopic analysis):
To investigate a new approach to prediction of radiation response, based on biochemical fingerprinting
Secondary Objectives:
- Overall survival and disease-free survival rates.
- To evaluate the significance of published prognostic/ stratification factors such as the UCSF-CAPRA score and assess their application to the data from this study.
- To achieve the maximum dose escalation (up to 81Gy). This will be assessed as the percentage of patients that receive each dose level for all categories (dose increments of 1.8 Gy from 75.6 Gy up to max 81 Gy).
- The incidence and severity of acute and late GU, GI and erectile dysfunction toxicities will be described, and correlated with DVH parameters.
- Conditions
- Prostate Cancer
- Being tested
- questionnaire administration, quality-of-life assessment, image-guided radiation therapy, intensity-modulated radiation therapy, radiation therapy treatment planning/simulation
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
image-guided radiation therapyRadiation
intensity-modulated radiation therapyRadiation
radiation therapy treatment planning/simulationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | Treatment will be delivered in 1.8 Gy fractions; dose escalation will be in 1.8 Gy increments from 75.6 Gy to a maximum 81 Gy. Receives: Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: image-guided radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: radiation therapy treatment planning/simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Failure Free survival
Measured: 7-9 years median follow-up
Secondary outcomes (3)
Overall survival and disease free survival rates
Measured: 5-7 years follow-up
Maximum dose escalation
Measured: 9 years follow-up
The incidence and severity of Genito-urinary (GU), Gastro-intestinal (GI) and erectile dysfunction (ED) toxicities (graded by NCI CTCAE Version 3.0) will be analysed and correlated with dose volume histogram (DVH) parameters.
Measured: 9 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study start20 Jul 2009
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- John Gerard Armstrong, MD, MB, MRCPI, Principal investigator, SLRON St Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951535
- Sponsor's protocol ID
- 08-17 ICORG
- Other IDs
- CTRIAL-IE 08-17
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2009
- Last updated
- 17 Apr 2026
- Results posted
- No
Publications
Medipally DK, Maguire A, Bryant J, Armstrong J, Dunne M, Finn M, Lyng FM, Meade AD. Development of a high throughput (HT) Raman spectroscopy method for rapid screening of liquid blood plasma from prostate cancer patients. Analyst. 2017 Apr 10;142(8):1216-1226. doi: 10.1039/c6an02100j.
PubMed 28001146Medipally DKR, Nguyen TNQ, Bryant J, Untereiner V, Sockalingum GD, Cullen D, Noone E, Bradshaw S, Finn M, Dunne M, Shannon AM, Armstrong J, Lyng FM, Meade AD. Monitoring Radiotherapeutic Response in Prostate Cancer Patients Using High Throughput FTIR Spectroscopy of Liquid Biopsies. Cancers (Basel). 2019 Jul 2;11(7):925. doi: 10.3390/cancers11070925.
PubMed 31269684Cagney DN, Dunne M, O'Shea C, Finn M, Noone E, Sheehan M, McDonagh L, O'Sullivan L, Thirion P, Armstrong J. Heterogeneity in high-risk prostate cancer treated with high-dose radiation therapy and androgen deprivation therapy. BMC Urol. 2017 Aug 1;17(1):60. doi: 10.1186/s12894-017-0250-2.
PubMed 28764689Meade AD, Maguire A, Bryant J, Cullen D, Medipally D, White L, McClean B, Shields L, Armstrong J, Dunne M, Noone E, Bradshaw S, Finn M, Shannon AM, Howe O, Lyng FM. Prediction of DNA damage and G2 chromosomal radio-sensitivity ex vivo in peripheral blood mononuclear cells with label-free Raman micro-spectroscopy. Int J Radiat Biol. 2019 Jan;95(1):44-53. doi: 10.1080/09553002.2018.1451006. Epub 2018 Mar 29.
PubMed 29528761
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer
- ClinicalTrials.gov ID
- NCT00951535
- Acronym / sponsor ID
- 08-17 ICORG
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 20 Jul 2009 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 al 2011).
Sub-Study 1 (Proteomic Analysis):
To use proteomic analysis of sequential blood and urine samples to detect changes in profiles that may predict outcome and identify prognostic biochemical markers of early disease progression and/ or toxicity. The unique molecular signatures may also allow the identification of targets for therapeutic intervention.
To undertake, where possible, other biochemical analyses including mRNA, miRNA and metabolite profiling.
Sub-Study 2 (Raman spectroscopic analysis):
To investigate a new approach to prediction of radiation response, based on biochemical fingerprinting
Secondary Objectives:
- Overall survival and disease-free survival rates.
- To evaluate the significance of published prognostic/ stratification factors such as the UCSF-CAPRA score and assess their application to the data from this study.
- To achieve the maximum dose escalation (up to 81Gy). This will be assessed as the percentage of patients that receive each dose level for all categories (dose increments of 1.8 Gy from 75.6 Gy up to max 81 Gy).
- The incidence and severity of acute and late GU, GI and erectile dysfunction toxicities will be described, and correlated with DVH parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Other: questionnaire administration, Procedure: quality-of-life assessment, Radiation: image-guided radiation therapy, Radiation: intensity-modulated radiation therapy, Radiation: radiation therapy treatment planning/simulationTreatment will be delivered in 1.8 Gy fractions; dose escalation will be in 1.8 Gy increments from 75.6 Gy to a maximum 81 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | Arm A |
| quality-of-life assessment | Procedure or surgery | Arm A |
| image-guided radiation therapy | Radiation | Arm A |
| intensity-modulated radiation therapy | Radiation | Arm A |
| radiation therapy treatment planning/simulation | Radiation | Arm A |
Primary outcome
Biochemical Failure Free survival
Time frame: 7-9 years median follow-up
3 secondary outcomes
Overall survival and disease free survival rates
Time frame: 5-7 years follow-up
Maximum dose escalation
Time frame: 9 years follow-up
The incidence and severity of Genito-urinary (GU), Gastro-intestinal (GI) and erectile dysfunction (ED) toxicities (graded by NCI CTCAE Version 3.0) will be analysed and correlated with dose volume histogram (DVH) parameters.
Time frame: 9 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 28001146Medipally DK, Maguire A, Bryant J, Armstrong J, Dunne M, Finn M, Lyng FM, Meade AD. Development of a high throughput (HT) Raman spectroscopy method for rapid screening of liquid blood plasma from prostate cancer patients. Analyst. 2017 Apr 10;142(8):1216-1226. doi: 10.1039/c6an02100j.
- Background: PubMed 31269684Medipally DKR, Nguyen TNQ, Bryant J, Untereiner V, Sockalingum GD, Cullen D, Noone E, Bradshaw S, Finn M, Dunne M, Shannon AM, Armstrong J, Lyng FM, Meade AD. Monitoring Radiotherapeutic Response in Prostate Cancer Patients Using High Throughput FTIR Spectroscopy of Liquid Biopsies. Cancers (Basel). 2019 Jul 2;11(7):925. doi: 10.3390/cancers11070925.
- Background: PubMed 28764689Cagney DN, Dunne M, O'Shea C, Finn M, Noone E, Sheehan M, McDonagh L, O'Sullivan L, Thirion P, Armstrong J. Heterogeneity in high-risk prostate cancer treated with high-dose radiation therapy and androgen deprivation therapy. BMC Urol. 2017 Aug 1;17(1):60. doi: 10.1186/s12894-017-0250-2.
- Derived from this study: PubMed 29528761Meade AD, Maguire A, Bryant J, Cullen D, Medipally D, White L, McClean B, Shields L, Armstrong J, Dunne M, Noone E, Bradshaw S, Finn M, Shannon AM, Howe O, Lyng FM. Prediction of DNA damage and G2 chromosomal radio-sensitivity ex vivo in peripheral blood mononuclear cells with label-free Raman micro-spectroscopy. Int J Radiat Biol. 2019 Jan;95(1):44-53. doi: 10.1080/09553002.2018.1451006. Epub 2018 Mar 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gerard Armstrong, MD, MB, MRCPI principal investigator
SLRON St Luke's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing questionnaire administration, quality-of-life assessment and image-guided radiation therapy in people with Prostate Cancer, run by Cancer Trials Ireland at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Failure Free survival (time frame: 7-9 years median follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00951535, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.