A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0 M0 Prostate Cancer. ICORG 08-17

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00951535
First received: August 1, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: image-guided radiation therapy
Radiation: intensity-modulated radiation therapy
Radiation: radiation therapy treatment planning/simulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Biochemical Failure Free survival [ Time Frame: 2017 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival and disease free survival rates [ Time Frame: 2017 ] [ Designated as safety issue: No ]
  • Maximum dose escalation [ Time Frame: 2017 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2017 ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: June 2008
Estimated Study Completion Date: September 2026
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A
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.
Other: questionnaire administration Procedure: quality-of-life assessment Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy Radiation: radiation therapy treatment planning/simulation

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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 nodes
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951535

Locations
Ireland
Saint Luke's Hospital Recruiting
Dublin, Ireland, 6
Contact: John Gerard Armstrong, MD, MB, MRCPI    +353 1 4065000      
UPMC Whitfield Cancer Centre Recruiting
Waterford, Ireland
Contact: Dayle Hacking    353 51 337444      
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00951535     History of Changes
Other Study ID Numbers: CDR0000639289, ICORG-08-17, EU-20924
Study First Received: August 1, 2009
Last Updated: August 11, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 15, 2014