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

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 - Late Toxicity of radiotherapy in prostate cancer patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44779

Enrollment

240

Registered

2013-02-04

Start date

2013-03-27

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

intermediate and high risk prostate cancer

Interventions

Patients will be randomized into two groups. One group will be treated with high dose external beam radiotherapy using the IMRT technique (standard treatment). The other group will be treated with e

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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+

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary objectives are to investigate the effect of this combined treatment on acute toxicity, tumour control, Quality of Life (QOL), overall survival, costs and cost-effectiveness compared to standard treatment with EBRT alone.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)