Curative Image Guided Radiotherapy for Prostate Cancer (RIC)

A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Radiation: radiotherapy daily verification reduced safety margins; Radiation: radiotherapy weekly verification standard safety margins

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital
  • Ålesund, Norway
    • Ålesund sykehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute rectal side effects	FWUO94	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		up to 10 years
Freedom from biochemical failure		3 years
Cancer specific survival		up to 10 years
Late genitourinary and rectal side effects		up to 10 years
Acute genitourinary side effects		10 weeks
quality of life	HRQoL	up to 10 years

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology; Alesund Hospital
• Investigators: Principal Investigator: Jo Å Lund, MD PhD, St Olavs Hospital, University Hospital, Trondheim, Norway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: adverse effects; radiotherapy, image-guided; position verification; safety margins
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2011/710

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No