Probach.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28094

Enrollment

240

Registered

2013-03-12

Start date

2013-03-20

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

prostate cancer radiotherapie HDR Brachytherapy intermediate risk

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 ext

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients ≤ 80 years with histologically proven adenocarcinoma of the prostate; 2. The following disease extensions are eligible: A. T1c-T2b with Gleason ≤ 6 and PSA 15-40 ng/ml, Nx, Mx*; B. T1c-T2b with Gleason 7 and PSA 10-30 ng/ml, Nx, Mx; C. T1c-T2b with Gleason 8 and PSA ¡Ü 10 ng/ml, Nx, Mx; D. T2c-T3a with Gleason ¡Ü 7 and PSA ¡Ü 15 ng/ml, Nx, Mx. *For patients with T3a, PSA > 20 and/or Gleason-score of 8 an evaluation of lymph node status and distant metastases have to be done before randomisation. These patients will be divided to 2 groups for stratification endpoints: i. Intermediate risk: T1c-T2c, G ≤7 and PSA <20 ng/ml; ii. (low) High risk: any of the following factors: T3, G 8, PSA ≥20. 3. Accessible for brachytherapy; 4. WHO performance status ≤ 2; 5. International Prostate Symptom Score (IPSS) ≤ 20; 6. Maximal urinary flow ≥ 10 ml/sec; 7. Post voiding residual bladder volume ≤ 200 ml; 8. Written informed consent; 9. Able to comply with follow-up; 10. Willing and able to complete the QOL questionnaires during follow-up.

Exclusion criteria

Exclusion criteria: 1. 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); 2. Metallic hip prosthesis; 3. Inflammatory bowel diseases such as colitis ulcerosa or M. Crohn in medical history; 4. Prior radiotherapy on prostate or pelvic area; 5. TURP; 6. Co-morbidity preventing general or spinal anaesthesia; 7. Very high risk patients ( PSA>40, G >8, T-stadium >T3a) beyond the above mentioned group; 8. T1-3, N+ M+.

Design outcomes

Primary

Measure	Time frame
The incidence of late gastro-intestinal and genito-urinary toxicity (grade ≥ 2 RTOG) during 3 years of follow-up after treatment completion.	—

Secondary

Measure	Time frame
Incidence of acute toxicity, bDFS, RFS, OS, QOL, costs and cost-effectiveness (all costs of treatment and during 5 years of FU after treatment completion).	—

Contacts

Public ContactRene Dercksen-Douma

Erasmus MC - Daniel den Hoed PO Box 5201

+31 (0)10 7041301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)