Know Cancer

forgot password

A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer

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

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 and GI toxicities will be described,
and correlated with DVH parameters

Inclusion Criteria:

1. 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)

2. Only patients requiring neo-adjuvant / adjuvant hormonal therapy will be included in
this study

3. Absence of distant metastases as demonstrated by history and physical examination,
FBC, screening profile including liver function tests, PSA and bone scan

4. 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.

5. No previous surgery for urinary conditions except TURP or TRUS

6. KPS > or equal to 60

7. Age >18 years

8. Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

1. Previous RT to the pelvic region

2. The patient has nodal involvement or it is decided to electively treat pelvic lymph

3. The patient has had a bilateral orchidectomy

4. The patient has previously received a full course of hormonal treatment for his
prostate cancer

5. The patient has or has had other malignancies within the last 5 years (non-melanoma
skin cancer is permitted)

6. 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

7. Patients who have had a prostatectomy

8. The presence of hip prostheses

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biochemical Failure Free survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

John Gerard Armstrong, MD, MB, MRCPI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital


Ireland: Research Ethics Committee

Study ID:




Start Date:

June 2008

Completion Date:

September 2026

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms