Which correction protocol gives the lowest cumulative rectal dose in prostate cancer patients who are treated with external beam radiotherapy? A phase II Modelling study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24967

Enrollment

Registered

2007-01-24

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum toxicity is the most important dose-limiting factor for radiotherapy of the prostate. As the trends towards dose escalation continue, margins are diminished and radiotherapy delivery starts to be adapted to the position variation of the prostate. An often used strategy is to correct for the position of the prostate based on implanted markers. Another way of correcting for the prostate movement is AMRT (adaptive margin radiotherapy). However for both methods little is known about its impli

Interventions

11 CT scans Patients will be treated according to standard care with high dose intensity modulated radiotherapy and gold marker based position correction. Furthermore they will undergo CT scans in tre

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven localized (cT1-3) adenocarcinoma of the prostate 1. Primary treatment for the prostate cancer with more than 70 Gy radiotherapy with curative intent; 2. WHO performance status 0-2; 3. The administration of concomitant hormonal therapy is allowed, however only if started more than 6 months before radiotherapy to limit the possibility of shrinkage of the prostate during the course of radiotherapy; 4. Be able to lie in lithotomy position; 5. Meet all MRI safety criteria.

Exclusion criteria

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 TUR-P in the last 3 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. coumarines or heparins), however the use of anti-platelet therapy is allowed; 7. No coagulation disorder.

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. D10% rectal wall, D50% rectal wall, D70% rectal wall; 2. D mean anal canal; 3. Crude cost analysis	—

Contacts

Public ContactM.A.D. Haverkort

Academisch Medisch Centrum, Afdeling Radiotherapie

m.a.haverkort@amc.nl0031-20-5663750

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)