RIC: Curative Image Guided Radiotherapy for Prostate Cancer

Sponsor

St. Olavs Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01550237

Collaborator

Norwegian University of Science and Technology (Other), Alesund Hospital (Other)

260

Enrollment

Locations

Arms

155

Duration (Months)

130

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Radiation: radiotherapy daily verification reduced safety margins Radiation: radiotherapy weekly verification standard safety margins	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Acute rectal side effects [10 weeks]
FWUO94

Secondary Outcome Measures

Freedom from biochemical failure [3 years]
Overall survival [up to 10 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 [up to 10 years]
HRQoL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olavs Hospital	Trondheim		Norway
2	Ålesund Sykehus	Ålesund		Norway

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

St. Olavs Hospital

ClinicalTrials.gov Identifier:

NCT01550237

Other Study ID Numbers:

2011/710

First Posted:

Mar 9, 2012

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by St. Olavs Hospital

radiotherapy, image-guided

adverse effects

position verification

safety margins

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Feb 17, 2022