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

NCT ID: NCT01717677

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 457 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radical prostatectomy

Procedure/Surgery: radical prostatectomy

Group Type: EXPERIMENTAL

radical prostatectomy

Intervention Type: PROCEDURE

percutaneous radiation therapy

Radiation: percutaneous radiation therapy

Group Type: EXPERIMENTAL

percutaneous radiation therapy

Intervention Type: RADIATION

permanent seed implantation

Radiation: permanent seed implantation

Group Type: EXPERIMENTAL

permanent seed implantation

Intervention Type: RADIATION

Active Surveillance

Procedure/Surgery: Active Surveillance

Group Type: EXPERIMENTAL

Active Surveillance

Intervention Type: PROCEDURE

Interventions

radical prostatectomy

Intervention Type: PROCEDURE

percutaneous radiation therapy

Intervention Type: RADIATION

permanent seed implantation

Intervention Type: RADIATION

Active Surveillance

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Association of Urologic Oncology (AUO)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Stöckle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Urologie und Kinderurologie der Universität des Saarlandes

Thomas Wiegel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Strahlentherapie und Radioonkologie der Universität Ulm

Locations

Universitätsklinikum

Ulm, Albert-Einstein-Allee 23, Germany

Universitätsklinikum

Homburg/Saar, Kirrberger Straße, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 32189088 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32886212 (View on PubMed)

Other Identifiers

DRKS00004405

Identifier Type: REGISTRY

Identifier Source: secondary_id

AP 65/11

Identifier Type: -

Identifier Source: org_study_id