Condition category
Cancer
Date applied
08/08/2011
Date assigned
26/09/2011
Last edited
20/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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 measures

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

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 life’s 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

http://www.umu.se/english

Funders

Funder type

Government

Funder name

Cancer Research Foundation (Sweden)

Alternative name(s)

CRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

1. http://www.ncbi.nlm.nih.gov/pubmed/11753990
2. http://www.ncbi.nlm.nih.gov/pubmed/18985545

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes