Clinical trial NCT01550237: Curative Image Guided Radiotherapy for Prostate Cancer
Official title: A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: radiotherapy, image-guided
adverse effects
position verification
safety margins
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Alesund Hospital
First posted: 2012-03-09
Enrollment: 260
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Acute rectal side effects
timeFrame: 10 weeks
Secondary outcomes:
measure: Freedom from biochemical failure
timeFrame: 3 years
measure: Overall survival
timeFrame: up to 10 years
measure: Cancer specific survival
timeFrame: up to 10 years
measure: Late genitourinary and rectal side effects
timeFrame: up to 10 years
measure: Acute genitourinary side effects
timeFrame: 10 weeks
measure: quality of life
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Ålesund
country: Norway
facility: Ålesund Sykehus
Study officials:
affiliation: St Olavs Hospital, University Hospital, Trondheim, Norway
name: Jo Å Lund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.