Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk (PREFERE)

February 8, 2021 updated by: Association of Urologic Oncology (AUO)

Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study will compare four possible therapy options for treatment of newly diagnosed prostate cancer with low or "early intermediate" risk according to the patients preferences.

The Following hypotheses will be tested:

  • Radiation is not relevantly worse compared to prostatectomy with regard to time to prostate cancer-related deaths
  • Permanent seed implantation therapy not inferior to prostatectomy with regard to time to prostate cancer-related deaths.
  • Active Surveillance does not lead to a significant decrease of time to prostate cancer-related deaths compared to prostatectomy.

That for patients with newly diagnosed prostate cancer will be randomized into one of the four treatment arms. Randomization may be limited to at least two of the four treatment arms if a patient refuses one or two of the four treatment arms according to his own preference.

Study Type

Interventional

Enrollment (Actual)

457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Albert-Einstein-Allee 23
      • Ulm, Albert-Einstein-Allee 23, Germany, 89081
        • Universitätsklinikum
    • Kirrberger Straße
      • Homburg/Saar, Kirrberger Straße, Germany, 66424
        • Universitätsklinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radical prostatectomy
Procedure/Surgery: radical prostatectomy
Procedure: radical prostatectomy
Experimental: percutaneous radiation therapy
Radiation: percutaneous radiation therapy
Radiation: percutaneous radiation therapy
Experimental: permanent seed implantation
Radiation: permanent seed implantation
Radiation: permanent seed implantation
Experimental: Active Surveillance
Procedure/Surgery: Active Surveillance
Procedure: Active Surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prostate cancer-specific survival
Time Frame: minimal observation time of 13 years for last study patient
minimal observation time of 13 years for last study patient

Secondary Outcome Measures

Outcome Measure
Time Frame
- Overall survival
Time Frame: minimal observation time of 13 years for last study patient
minimal observation time of 13 years for last study patient
- Time to onset of hormone therapy
Time Frame: 17 years
17 years
- Occurrence of the first progression on hormone therapy
Time Frame: 17 years
17 years
- Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
Time Frame: before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
- Complications / Safety
Time Frame: median 15 years
median 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Urologic Oncology (AUO)

Investigators

  • Principal Investigator: Michael Stöckle, Prof. Dr., Klinik für Urologie und Kinderurologie der Universität des Saarlandes
  • Principal Investigator: Thomas Wiegel, Prof. Dr., Klinik für Strahlentherapie und Radioonkologie der Universität Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP 65/11
  • DRKS00004405 (Registry Identifier: Freiburger Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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