Condition category
Cancer
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
04/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M A D Haverkort

ORCID ID

Contact details

Academisch Medisch Centrum
Afdeling Radiotherapie
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 3750
m.a.haverkort@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC 06/268

Study information

Scientific title

Acronym

Study hypothesis

To reduce cumulative radiation dose in the rectum in prostate cancer patients who are treated with curative intent using external beam radiotherapy. We will investigate whether position correction based on implanted gold markers or re-planning based on sequential Computed Tomography (CT) scans (adaptive margin strategy) is required instead of standard position correction protocols based on bony anatomy. With this knowledge we intend to develop a new treatment protocol for patients with prostate cancer for our department.

Ethics approval

Approval received from the local medical ethics committee (Medische Etische Commissie Academisch Medisch Centrum) on the 19th December 2006 (ref: MEC 06/268).

Study design

Prospective phase II modeling study

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

External beam radiotherapy, prostatic neoplasms, rectal toxicity, position verification

Intervention

Before the start of the treatment four gold seeds will be implanted in the prostate of the patients. Treatment consists of external beam radiotherapy (77 - 78 Gy) with curative intent. During radiotherapy the prostate position will be measured daily using Portal Imaging (PI) of the gold seeds and bony anatomy and treatment position corrections will be performed using standard daily offline correction protocols for optimal prostate treatment.

In addition to the standard treatment, a CT scan will be performed every day during the first week and once a week thereafter. After the first week an ‘Adaptive Margin Radiotherapy’ (AMRT) treatment plan will be made, considering both averaged prostate and rectum positions in the first five scans. The cumulative rectum dose will be computed for the original treatment plan, considering repositioning based on PI for bony anatomy and markers and considering the adaptive margin strategy.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

D30% rectal wall (the minimum dose in 30% of the rectal wall that receives the highest dose) from the cumulative dose-volume-histograms

Secondary outcome measures

1. D10% rectal wall, D50% rectal wall, D70% rectal wall
2. D mean anal canal
3. Crude cost analysis

Overall trial start date

01/02/2007

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven localised (cT1-3) adenocarcinoma of the prostate
2. Primary treatment for the prostate cancer with more than 70 Gy radiotherapy with curative intent
3. World Health Organisation (WHO) performance status zero to two
4. The administration of concomitant hormonal therapy is allowed, however only if started more than six months before radiotherapy to limit the possibility of shrinkage of the prostate during the course of radiotherapy
5. Be able to lie in lithotomy position
6. Meet all Magnetic Resonance Imaging (MRI) safety criteria

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. No hip prosthesis
2. No involvement of pelvic lymph node assessed by CT scan or laparoscopic surgery
3. No evidence of distant metastases
4. No Transurethral Resection of the Prostate (TUR-P) in the last three months
5. No anorectal surgery in the past or other situations in which the anorectal anatomy is abnormal
6. No use of anticoagulation therapy (i.e. coumarins or heparins), however the use of anti-platelet therapy is allowed
7. No coagulation disorder

Recruitment start date

01/02/2007

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academisch Medisch Centrum
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Radiotherapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

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

Publication citations

Additional files

Editorial Notes