Curative Image Guided Radiotherapy for Prostate Cancer

Prostatic Neoplasms Clinical Trial

— RIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01550237
• Other study ID #: 2011/710
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: September 2025
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
Norway	Ålesund Sykehus	Ålesund
Norway	St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Alesund Hospital, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & 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 irradiat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rectal side effects	FWUO94	10 weeks
Secondary	Freedom from biochemical failure		3 years
Secondary	Overall survival		up to 10 years
Secondary	Cancer specific survival		up to 10 years
Secondary	Late genitourinary and rectal side effects		up to 10 years
Secondary	Acute genitourinary side effects		10 weeks
Secondary	quality of life	HRQoL	up to 10 years