NCT01550237

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

March 7, 2012

Last Update Submit

June 4, 2025

Conditions

Prostatic Neoplasms

Keywords

radiotherapy, image-guidedadverse effectsposition verificationsafety margins

Outcome Measures

Primary Outcomes (1)

  • Acute rectal side effects

    FWUO94

    10 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

radiotherapy daily reduced

EXPERIMENTAL

radiotherapy, with daily CT position verification and reduced safety margins

Radiation: radiotherapy daily verification reduced safety margins

radiotherapy weekly standard

ACTIVE COMPARATOR

radiotherapy, with weekly orthogonal position verification and standard safety margins

Radiation: radiotherapy weekly verification standard safety margins

Interventions

radiotherapy daily verification reduced safety marginsRADIATION

curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)

radiotherapy daily reduced
radiotherapy weekly verification standard safety marginsRADIATION

curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)

radiotherapy weekly standard

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ålesund Sykehus

Ålesund, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 29398152RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jo Å Lund, MD PhD

    St Olavs Hospital, University Hospital, Trondheim, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2025

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

NO(2)