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Active, Not Recruiting

NCT Number: NCT01550237

Curative Image Guided Radiotherapy 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital, Trondheim, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiotherapy daily verification reduced safety margins

Radiation

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

radiotherapy weekly verification standard safety margins

Radiation

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

Primary outcomes

  1. Acute rectal side effects

    Time frame: 10 weeks

    FWUO94

Secondary outcomes

  1. Freedom from biochemical failure

    Time frame: 3 years

  2. Overall survival

    Time frame: up to 10 years

  3. Cancer specific survival

    Time frame: up to 10 years

  4. Late genitourinary and rectal side effects

    Time frame: up to 10 years

  5. Acute genitourinary side effects

    Time frame: 10 weeks

  6. quality of life

    Time frame: up to 10 years

    HRQoL

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Alesund Hospital
  • Norwegian University of Science and Technology

Registry information

Official study title

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

Acronym: RIC

Important dates

Study start
2012
Primary completion
2015
Study completion
2025
First posted
Mar 9, 2012
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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