Curative Image Guided Radiotherapy for Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostatic Neoplasms

• Registration Number: NCT01550237
• Lead Sponsor: St. Olavs Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-09
• Study Start: 2012-10
• Primary Completion: 2015-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acute rectal side effects	10 weeks	FWUO94

Secondary Outcome Measures

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

Trial Locations

Locations (2)

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Ålesund Sykehus; 🇳🇴 Ålesund, Norway