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Curative Image Guided Radiotherapy for Prostate Cancer (RIC)

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ClinicalTrials.gov Identifier: NCT01550237
Recruitment Status : Active, not recruiting
First Posted : March 9, 2012
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Alesund Hospital
Information provided by (Responsible Party):
St. Olavs Hospital

Tracking Information
First Submitted Date  ICMJE March 7, 2012
First Posted Date  ICMJE March 9, 2012
Last Update Posted Date February 12, 2019
Study Start Date  ICMJE October 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Acute rectal side effects [ Time Frame: 10 weeks ]
FWUO94
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01550237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
  • Freedom from biochemical failure [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: up to 10 years ]
  • Cancer specific survival [ Time Frame: up to 10 years ]
  • Late genitourinary and rectal side effects [ Time Frame: up to 10 years ]
  • Acute genitourinary side effects [ Time Frame: 10 weeks ]
  • quality of life [ Time Frame: up to 10 years ]
    HRQoL
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curative Image Guided Radiotherapy for Prostate Cancer
Official Title  ICMJE A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: radiotherapy daily reduced
    radiotherapy, with daily CT position verification and reduced safety margins
    Intervention: Radiation: radiotherapy daily verification reduced safety margins
  • Active Comparator: radiotherapy weekly standard
    radiotherapy, with weekly orthogonal position verification and standard safety margins
    Intervention: Radiation: radiotherapy weekly verification standard safety margins
Publications * Tøndel H, Lund JÅ, Lydersen S, Wanderås AD, Aksnessæther B, Jensen CA, Kaasa S, Solberg A. Radiotherapy for prostate cancer - Does daily image guidance with tighter margins improve patient reported outcomes compared to weekly orthogonal verified irradiation? Results from a randomized controlled trial. Radiother Oncol. 2018 Feb;126(2):229-235. doi: 10.1016/j.radonc.2017.10.029. Epub 2018 Feb 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 7, 2012)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2025
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550237
Other Study ID Numbers  ICMJE 2011/710
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Olavs Hospital
Study Sponsor  ICMJE St. Olavs Hospital
Collaborators  ICMJE
  • Norwegian University of Science and Technology
  • Alesund Hospital
Investigators  ICMJE
Principal Investigator: Jo Å Lund, MD PhD St Olavs Hospital, University Hospital, Trondheim, Norway
PRS Account St. Olavs Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP