Curative Image Guided Radiotherapy for Prostate Cancer (RIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Olavs Hospital
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Alesund Hospital
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01550237
First received: March 7, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome.

An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).


Condition Intervention
Prostatic Neoplasms
Radiation: radiotherapy daily verification reduced safety margins
Radiation: radiotherapy weekly verification standard safety margins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Acute rectal side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    FWUO94


Secondary Outcome Measures:
  • Freedom from biochemical failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Cancer specific survival [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Late genitourinary and rectal side effects [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Acute genitourinary side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    HRQoL


Estimated Enrollment: 260
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiotherapy daily reduced
radiotherapy, with daily CT position verification and reduced safety margins
Radiation: radiotherapy daily verification reduced safety margins
curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
Active Comparator: radiotherapy weekly standard
radiotherapy, with weekly orthogonal position verification and standard safety margins
Radiation: radiotherapy weekly verification standard safety margins
curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed adenocarcinoma of prostate
  • No evidence of nodal or distant metastases (N0M0)
  • Intermediate or high risk based on T stage, PSA level and Gleason score
  • Informed consent

Exclusion Criteria:

  • Previous treatment for cancer last 5 years, except basal cell carcinoma of skin
  • Any previous radiotherapy, except KV or electron treatment of skin tumors outside the pelvis
  • Metallic hip joint replacement
  • Pre-existing intestinal or genitourinary disease with increased risk of side effects
  • Any pre-existing condition making the patient unsuitable for radiotherapy
  • Any pre-existing condition making the patient unsuitable for hormonal therapy
  • Any pre-existing condition making the patient unsuitable for MRI.
  • ALAT, GT, ALP, creatinin > 1.5 x upper normal limit
  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: NCT01550237

Contacts
Contact: Jo Å Lund, MD PhD +47 73867830 jo-asmund.lund@stolav.no
Contact: A Solberg, MD +47 72825359 arne.solberg@ntnu.no

Locations
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Arne Solberg, MD         
Contact: Jo Å Lund, MD PhD         
Ålesund Sykehus Recruiting
Ålesund, Norway
Contact: Bjørg Aksnesaether, MD         
Contact: O Klepp, MD PhD         
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Alesund Hospital
Investigators
Principal Investigator: Jo Å Lund, MD PhD St Olavs Hospital, University Hospital, Trondheim, Norway
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01550237     History of Changes
Other Study ID Numbers: 2011/710
Study First Received: March 7, 2012
Last Updated: April 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
radiotherapy, image-guided
adverse effects
position verification
safety margins

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

ClinicalTrials.gov processed this record on October 20, 2014