Randomized Phase 3 Study On The Assessment Of Late Toxicity By Comparing IMRT High Dose External Beam Radiotherapy Only With External Beam Radiotherapy Combined With HDR Or PDR Brachytherapy In Patients With Intermediate/high Risk Prostate Cancer

Phase 3

Completed

• Conditions: intermediate and high risk prostate cancer; 10038364

• Registration Number: NL-OMON44779
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

T1c-T2a with Gleason * 6 and PSA 15-60 ng/ml, N0/x, M0
prostate carcinoma
T1c-T2a with Gleason 7 and PSA 10-50 ng/ml, N0/x, M0
T1c-T2c with Gleason 8 and PSA * 20ng/ml, N0/x, M0
T2b-T3a with Gleason * 7 and PSA * 40ng/ml, N0/x, M0
* Accessible for brachytherapy
* WHO performance status * 2
* International Prostate Symptom Score (IPSS) * 20 (appendix F)
* Maximal urinary flow * 10 ml/sec
* Post voiding residual bladder volume * 200 ml
* Written informed consent

Exclusion Criteria

* Other malignancy (except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years)
* Metallic hip prothesis
* Inflammatory bowel diseases such as colitis ulcerosa or M. Crohn in medical history
* Prior radiotherapy on prostate or pelvic area
* TURP
* Co-morbidity preventing general or spinal anaesthesia
* Very high risk patients ( PSA>60, G >8, T-stadium >T3a) beyond the above mentioned group.
* T1-3, N+,M+

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study objective is to show a 50% reduction of the incidence of<br /><br>long-term gastrointestinal and genito-urinary toxicity in the treatment of<br /><br>prostate cancer in the intermediate and high risk group, by treatment with EBRT<br /><br>followed by brachytherapy (EBRT+BRACHY), compared to treatment with EBRT alone<br /><br>(EBRT). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to investigate the effect of this combined treatment<br /><br>on acute toxicity, tumour control, Quality of Life (QOL), overall survival,<br /><br>costs and cost-effectiveness compared to standard treatment with EBRT alone.</p><br>