Plain English Summary
Background and study aims
Prostate cancer is a common cancer, where many patients have such a slowly growing tumor that it is uncertain if they need treatment. Other patients have very aggressive tumors, and in Sweden with 10000 newly diagnosed prostate cancer patients 2500 will die each year. No scientific studies had in 1986 shown that any of the treatment options for localized prostate cancer expectancy or radiotherapy or surgery was superior. Expectancy had been the treatment of choice in the beginnings of the 1980s. The aim of this study was to evaluate if radiotherapy could prolong progression free survival and reduce mortality in comparison to expectancy.
Who can participate?
Patients with prostate cancer under the age of 75
What does the study involve?
Participants are followed for the progression of their symptoms and are offered radiotherapy. The use of four-field EBRT, 64 Gy, 2.0 cm margin was increased during the beginning of 1980’s, further technical improvements such as CT-based conformal radiotherapy was developed by the beginning of the 1990ies, dose was increased to 70 Gy with margins around 1-1.5 cm.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Umeå University (Sweden)
When is study starting and how long is it expected to run for?
April 1986 to January 1997
Who is funding the study?
1. Cancer Research Foundation (Sweden)
2. Lions Cancer Research Foundation, Umeå University (Sweden)
3. Umeå University Hospital (Sweden)
Who is the main contact?
Professor Andrew Widmark
Anders.Widmark@onkologi.umu.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Anders Widmark
ORCID ID
Contact details
Umeå University
Department of Radiation Sciences
Oncology
Umeå
SE - 90187
Sweden
+46 (0) 90 785 2857
Anders.Widmark@onkologi.umu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1991 and 1995 04
Study information
Scientific title
External radiotherapy versus expectancy in low-intermediate risk localized prostate cancer: a randomized trial
Acronym
Study hypothesis
To investigate if radiotherapy will prolong progression free survival and reduce mortality in prostate cancer in early localized prostate cancer in comparison to active expectancy.
Ethics approval
Study was part of the regular treatment program for localized prostate cancer in Northern Sweden (Ethics approval not necessary at that time [1996]).
Study design
Randomized open multi-center trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
Expectancy: Patients included: 107 out of (130) 160, Patients followed until symptomatic clinical progression, and then offered radiotherapy
Radiotherapy: Patients included: 107 out of (130) 160, Treated with 64-70 Gy, boxfield or conformal radiotherapy, and than follow up, until clinical progression and than castration treatment
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
1. Progression Free survival
2. Overall survival
Secondary outcome measures
Morbidity
Overall trial start date
23/04/1986
Overall trial end date
27/01/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with verified localized prostate cancer, T1-T2b, pN0, Grade 1 and 2, M0
2. Age less than or equal to 75 years
3. Surgical obturatorious lymph node staging, with no signs of positive lymph nodes
4. No signs on metastasis after clinical investigation, bone scan and pulmonary X-ray
5. No previous treatment against their prostate cancer
6. No other known malign or benign disease that would shorten their lifes in relation to a healthy population
7. Patients approval of participation
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
260 (revised to 320)
Participant exclusion criteria
Patients not willing to participate in the long follow up program
Recruitment start date
23/04/1986
Recruitment end date
27/01/1997
Locations
Countries of recruitment
Denmark, Norway, Sweden
Trial participating centre
Umeå University
Umeå
SE - 90187
Sweden
Sponsor information
Organisation
Umeå University Hospital (Sweden)
Sponsor details
c/o Prof Anders Widmark
Umeå
SE - 901 87
Sweden
+46 (0)90 785 2857
Anders.Widmark@onkologi.umu.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Cancer Research Foundation (Sweden)
Alternative name(s)
CRF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Funder name
Lions Cancer Research Foundation, Umeå University (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Umeå university Hospital, Umeå (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. http://www.ncbi.nlm.nih.gov/pubmed/11753990
2. http://www.ncbi.nlm.nih.gov/pubmed/18985545
Publication citations
-
Fransson P, Damber JE, Tomic R, Modig H, Nyberg G, Widmark A, Quality of life and symptoms in a randomized trial of radiotherapy versus deferred treatment of localized prostate carcinoma., Cancer, 2001, 92, 12, 3111-3119.
-
Fransson P, Damber JE, Widmark A, Health-related quality of life 10 years after external beam radiotherapy or watchful waiting in patients with localized prostate cancer., Scand. J. Urol. Nephrol., 2009, 43, 2, 119-126, doi: 10.1080/00365590802519396.