External radiotherapy versus expectancy in localized prostate cancer

ISRCTN	ISRCTN36505257
DOI	https://doi.org/10.1186/ISRCTN36505257
Secondary identifying numbers	Version 1991 and 1995 04

Submission date: 08/08/2011
Registration date: 26/09/2011
Last edited: 19/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Anders Widmark
Scientific

Umeå University
Department of Radiation Sciences, Oncology
Umeå
SE - 90187
Sweden

Phone	+46 (0) 90 785 2857
Email	Anders.Widmark@onkologi.umu.se

Study information

Study design	Randomized open multi-center trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	External radiotherapy versus expectancy in low-intermediate risk localized prostate cancer: a randomized trial
Study objectives	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(s)	Study was part of the regular treatment program for localized prostate cancer in Northern Sweden (Ethics approval not necessary at that time [1996]).
Health condition(s) or problem(s) studied	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
Primary outcome measure	1. Progression Free survival 2. Overall survival
Secondary outcome measures	Morbidity
Overall study start date	23/04/1986
Completion date	27/01/1997

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	260 (revised to 320)
Key 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
Key exclusion criteria	Patients not willing to participate in the long follow up program
Date of first enrolment	23/04/1986
Date of final enrolment	27/01/1997

Locations

Countries of recruitment

Denmark
Norway
Sweden

Study participating centre

Umeå University

Umeå
SE - 90187
Sweden

Sponsor information

Umeå University Hospital (Sweden)
Hospital/treatment centre

c/o Prof Anders Widmark
Umeå
SE - 901 87
Sweden

Phone	+46 (0)90 785 2857
Email	Anders.Widmark@onkologi.umu.se
Website	http://www.umu.se/english
"ROR"	https://ror.org/012k96e85

Funders

Funder type

Government

Cancer Research Foundation (Sweden)
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): The Cancer Research Foundation, CRF
Location: United States of America

Lions Cancer Research Foundation, Umeå University (Sweden)

No information available

Umeå university Hospital, Umeå (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications		15/12/2001		Yes	No
Other publications		01/12/2009		Yes	No

Editorial Notes

19/05/2017: Plain English summary added.