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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
radical prostatectomy
percutaneous radiation therapy
permanent seed implantation
Active Surveillance
Sponsored by
Association of Urologic Oncology (AUO)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum
  • Universitätsklinikum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

radical prostatectomy

percutaneous radiation therapy

permanent seed implantation

Active Surveillance

Arm Description

Procedure/Surgery: radical prostatectomy

Radiation: percutaneous radiation therapy

Radiation: permanent seed implantation

Procedure/Surgery: Active Surveillance

Outcomes

Primary Outcome Measures

Prostate cancer-specific survival

Secondary Outcome Measures

- Overall survival
- Time to onset of hormone therapy
- Occurrence of the first progression on hormone therapy
- Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
- Complications / Safety

Full Information

First Posted
October 26, 2012
Last Updated
February 8, 2021
Sponsor
Association of Urologic Oncology (AUO)
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1. Study Identification

Unique Protocol Identification Number
NCT01717677
Brief Title
Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Acronym
PREFERE
Official Title
Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Recruitment
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association of Urologic Oncology (AUO)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radical prostatectomy
Arm Type
Experimental
Arm Description
Procedure/Surgery: radical prostatectomy
Arm Title
percutaneous radiation therapy
Arm Type
Experimental
Arm Description
Radiation: percutaneous radiation therapy
Arm Title
permanent seed implantation
Arm Type
Experimental
Arm Description
Radiation: permanent seed implantation
Arm Title
Active Surveillance
Arm Type
Experimental
Arm Description
Procedure/Surgery: Active Surveillance
Intervention Type
Procedure
Intervention Name(s)
radical prostatectomy
Intervention Type
Radiation
Intervention Name(s)
percutaneous radiation therapy
Intervention Type
Radiation
Intervention Name(s)
permanent seed implantation
Intervention Type
Procedure
Intervention Name(s)
Active Surveillance
Primary Outcome Measure Information:
Title
Prostate cancer-specific survival
Time Frame
minimal observation time of 13 years for last study patient
Secondary Outcome Measure Information:
Title
- Overall survival
Time Frame
minimal observation time of 13 years for last study patient
Title
- Time to onset of hormone therapy
Time Frame
17 years
Title
- Occurrence of the first progression on hormone therapy
Time Frame
17 years
Title
- 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
Title
- Complications / Safety
Time Frame
median 15 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stöckle, Prof. Dr.
Organizational Affiliation
Klinik für Urologie und Kinderurologie der Universität des Saarlandes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Wiegel, Prof. Dr.
Organizational Affiliation
Klinik für Strahlentherapie und Radioonkologie der Universität Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum
City
Ulm
State/Province
Albert-Einstein-Allee 23
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum
City
Homburg/Saar
State/Province
Kirrberger Straße
ZIP/Postal Code
66424
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32189088
Citation
Albers 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.
Results Reference
result
PubMed Identifier
32886212
Citation
Wiegel 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. Erratum In: J Cancer Res Clin Oncol. 2020 Dec 21;:
Results Reference
result

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

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