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Curative Image Guided Radiotherapy for Prostate Cancer (RIC)

Primary Purpose

Prostatic Neoplasms

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
radiotherapy daily verification reduced safety margins
radiotherapy weekly verification standard safety margins
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring radiotherapy, image-guided, adverse effects, position verification, safety margins

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • St Olavs Hospital
  • Ålesund Sykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

radiotherapy daily reduced

radiotherapy weekly standard

Arm Description

radiotherapy, with daily CT position verification and reduced safety margins

radiotherapy, with weekly orthogonal position verification and standard safety margins

Outcomes

Primary Outcome Measures

Acute rectal side effects
FWUO94

Secondary Outcome Measures

Freedom from biochemical failure
Overall survival
Cancer specific survival
Late genitourinary and rectal side effects
Acute genitourinary side effects
quality of life
HRQoL

Full Information

First Posted
March 7, 2012
Last Updated
March 8, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Alesund Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01550237
Brief Title
Curative Image Guided Radiotherapy for Prostate Cancer
Acronym
RIC
Official Title
A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Alesund Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
radiotherapy, image-guided, adverse effects, position verification, safety margins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy daily reduced
Arm Type
Experimental
Arm Description
radiotherapy, with daily CT position verification and reduced safety margins
Arm Title
radiotherapy weekly standard
Arm Type
Active Comparator
Arm Description
radiotherapy, with weekly orthogonal position verification and standard safety margins
Intervention Type
Radiation
Intervention Name(s)
radiotherapy daily verification reduced safety margins
Intervention Description
curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
Intervention Type
Radiation
Intervention Name(s)
radiotherapy weekly verification standard safety margins
Intervention Description
curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)
Primary Outcome Measure Information:
Title
Acute rectal side effects
Description
FWUO94
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Freedom from biochemical failure
Time Frame
3 years
Title
Overall survival
Time Frame
up to 10 years
Title
Cancer specific survival
Time Frame
up to 10 years
Title
Late genitourinary and rectal side effects
Time Frame
up to 10 years
Title
Acute genitourinary side effects
Time Frame
10 weeks
Title
quality of life
Description
HRQoL
Time Frame
up to 10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Å Lund, MD PhD
Organizational Affiliation
St Olavs Hospital, University Hospital, Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Ålesund Sykehus
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29398152
Citation
Tondel H, Lund JA, Lydersen S, Wanderas AD, Aksnessaether 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.
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Curative Image Guided Radiotherapy for Prostate Cancer

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