External radiotherapy versus expectancy in localized prostate cancer
| ISRCTN | ISRCTN36505257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36505257 |
| Protocol serial number | Version 1991 and 1995 04 |
| Sponsor | Umeå University Hospital (Sweden) |
| Funders | Cancer Research Foundation (Sweden), Lions Cancer Research Foundation, Umeå University (Sweden), Umeå university Hospital, Umeå (Sweden) |
- 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
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
Scientific
Umeå University
Department of Radiation Sciences, Oncology
Umeå
SE - 90187
Sweden
| Phone | +46 (0) 90 785 2857 |
|---|---|
| Anders.Widmark@onkologi.umu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized open multi-center trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Progression Free survival |
| Key secondary outcome measure(s) |
Morbidity |
| Completion date | 27/01/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
SE - 90187
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/05/2017: Plain English summary added.
