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

This study is not yet open for participant recruitment.
Verified November 2012 by Association of Urogenital Oncology (AUO)
Sponsor:
Information provided by (Responsible Party):
Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier:
NCT01717677
First received: October 26, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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 brachytherapy
Procedure: Active Surveillance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Prostate cancer-specific survival [ Time Frame: maximal observation time of 17 years for first study patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Overall survival [ Time Frame: maximal observation time of 17 years for first study patient ] [ Designated as safety issue: No ]
  • - Time to onset of hormone therapy [ Time Frame: 17 years ] [ Designated as safety issue: No ]
  • - Occurrence of the first progression on hormone therapy [ Time Frame: 17 years ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • - Complications / Safety [ Time Frame: 17 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 7600
Study Start Date: December 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 brachytherapy
Radiation: permanent seed Brachytherapy
 Radiation: permanent seed brachytherapy
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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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 carcinoma-in-situ)
  • contraindications for prostatectomy, radiation therapy or Active Surveillance
  • Patients refusing written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717677

Contacts
Contact: Roswitha Bussar-Maatz (0)30 322 932 946 bussar-maatz@krebsgesellschaft.de

Locations
Germany
Universitätsklinikum Not yet recruiting
Ulm, Albert-Einstein-Allee 23, Germany, 89081
Contact: Thomas Wiegel, Prof. Dr.     0731-50056101     thomas.wiegel@uniklinik-ulm.de    
Principal Investigator: Thomas Wiegel            
Universitätsklinikum Not yet recruiting
Homburg/Saar, Kirrberger Straße, Germany, 66424
Contact: Michael Stöckle, Prof. Dr.     06841/162-47 02     michael.stoeckle@uks.eu    
Principal Investigator: Michael Stöckle, Prof. Dr.            
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 Klinik für Strahlentherapie und Radioonkologie der Universität Ulm
  More Information

No publications provided

Responsible Party: Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01717677     History of Changes
Other Study ID Numbers: AP 65/11, DRKS00004405
Study First Received: October 26, 2012
Last Updated: November 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013