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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717677
First Posted: October 30, 2012
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Association of Urogenital Oncology (AUO)
  Purpose
4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk

Condition Intervention
Prostate Cancer Procedure: radical prostatectomy Radiation: percutaneous radiation therapy Radiation: permanent seed implantation Procedure: Active Surveillance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

Resource links provided by NLM:


Further study details as provided by Association of Urogenital Oncology (AUO):

Primary Outcome Measures:
  • Prostate cancer-specific survival [ Time Frame: minimal observation time of 13 years for last study patient ]

Secondary Outcome Measures:
  • - Overall survival [ Time Frame: minimal observation time of 13 years for last study patient ]
  • - Time to onset of hormone therapy [ Time Frame: 17 years ]
  • - Occurrence of the first progression on hormone therapy [ Time Frame: 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 ]
  • - Complications / Safety [ Time Frame: median 15 years ]

Estimated Enrollment: 7600
Study Start Date: October 2012
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2029 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717677


Locations
Germany
Universitätsklinikum
Ulm, Albert-Einstein-Allee 23, Germany, 89081
Universitätsklinikum
Homburg/Saar, Kirrberger Straße, Germany, 66424
Sponsors and Collaborators
Association of Urogenital 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
  More Information

Responsible Party: Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01717677     History of Changes
Other Study ID Numbers: AP 65/11
DRKS00004405 ( Registry Identifier: Freiburger Register )
First Submitted: October 26, 2012
First Posted: October 30, 2012
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases