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

NCT01717677 | Terminated DMC

• 2 other identifiers: AP 65/11DRKS00004405
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prostate cancer-specific survival

  minimal observation time of 13 years for last study patient

Secondary Outcomes (5)

• - Overall survival

  minimal observation time of 13 years for last study patient

• - Time to onset of hormone therapy

  17 years

• - Occurrence of the first progression on hormone therapy

  17 years

• - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline

  before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years

• - Complications / Safety

  median 15 years

Study Arms (4)

radical prostatectomy

EXPERIMENTAL

Procedure/Surgery: radical prostatectomy

Procedure: radical prostatectomy

percutaneous radiation therapy

EXPERIMENTAL

Radiation: percutaneous radiation therapy

Radiation: percutaneous radiation therapy

permanent seed implantation

EXPERIMENTAL

Radiation: permanent seed implantation

Radiation: permanent seed implantation

Active Surveillance

EXPERIMENTAL

Procedure/Surgery: Active Surveillance

Procedure: Active Surveillance

Interventions

radical prostatectomy PROCEDURE

radical prostatectomy

percutaneous radiation therapy RADIATION

percutaneous radiation therapy

permanent seed implantation RADIATION

permanent seed implantation

Active Surveillance PROCEDURE

Active Surveillance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Urologic Oncology (AUO): lead

Study Sites (2)

Universitätsklinikum

Ulm, Albert-Einstein-Allee 23, 89081, Germany

Location

Universitätsklinikum

Homburg/Saar, Kirrberger Straße, 66424, Germany

Location

Related Publications (2)

• 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.

  PMID: 32189088 RESULT

• 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.

  PMID: 32886212 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: January 31, 2018
• Study Completion: April 30, 2018
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

DE (2)