Clinical trial · Interventional
Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
NCT01717677CI-TRIAL-00049992PREFEREterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Recruitment
Summary
Brief summary (as posted)
4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Surveillance | Procedure | — | UNRESOLVED |
| percutaneous radiation therapy | Radiation | — | UNRESOLVED |
| permanent seed implantation | Radiation | — | UNRESOLVED |
| radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- radical prostatectomy
- description
- Procedure/Surgery: radical prostatectomy
- interventionNames
- Procedure: radical prostatectomy
- type
- EXPERIMENTAL
- label
- percutaneous radiation therapy
- description
- Radiation: percutaneous radiation therapy
- interventionNames
- Radiation: percutaneous radiation therapy
- type
- EXPERIMENTAL
- label
- permanent seed implantation
- description
- Radiation: permanent seed implantation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol) * Men aged 18-75 years * Recruitment within 3 months after histological confirmation * Localized prostata cancer \<= cT2a, NX or N0 M0 * PSA \<= 10 ng / ml * Gleason score \<= 7a (3 +4) * ECOG performance status 0 or 1 * \<= 30% positive biopsy cores with largest contiguous tumor length \<= 5 mm * IPSS score \< 18 * Urine flow (Qmax):\> 15 ml / s Exclusion Criteria: * Unifocal Gleason 6 cancer \<1mm * History of treatment for BPH e.g. TURP, HIFU or cryotherapy * History of radiation therapy to the pelvis * Life expectancy \<10 years * ASA \>= 4 * Post-void residual urine \> 50 ml * Prostate volume on transrectal ultrasound \> 60 cm3 * large median prostate lobe visualized on transrectal ultrasound * chronic intestinal inflammatory disease covering the rectum * Other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma) * contraindications for prostatectomy, radiation therapy or Active Surveillance * Patients refusing written informed consent
References
Publications (2)
- RESULTAlbers P, Wiegel T, Schmidberger H, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Meisner C, Wellek S, Grozinger K, Renner P, Burmester M, Schneider F, Stockle M. Termination rates and histological reclassification of active surveillance patients with low- and early intermediate-risk prostate cancer: results of the PREFERE trial. World J Urol. 2021 Jan;39(1):65-72. doi: 10.1007/s00345-020-03154-7. Epub 2020 Mar 18. PMID 32189088
- RESULTWiegel T, Albers P, Bartkowiak D, Bussar-Maatz R, Harter M, Kristiansen G, Martus P, Wellek S, Schmidberger H, Grozinger K, Renner P, Schneider F, Burmester M, Stockle M. Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial). J Cancer Res Clin Oncol. 2021 Jan;147(1):235-242. doi: 10.1007/s00432-020-03327-2. Epub 2020 Sep 4. PMID 32886212