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

Prostate Cancer Clinical Trial

— PREFERE  

Official title:

Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01717677
• Other study ID #: AP 65/11
• Secondary ID: DRKS00004405
• Status: Terminated
• Phase: N/A
• Start date: October 2012
• Est. completion date: April 30, 2018

Study information

• Verified date: February 2021
• Source: Association of Urologic Oncology (AUO)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 457
• Est. completion date: April 30, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• radical prostatectomy

Radiation:
• percutaneous radiation therapy

• permanent seed implantation

Procedure:
• Active Surveillance

Locations

Country	Name	City	State
Germany	Universitätsklinikum	Homburg/Saar	Kirrberger Straße
Germany	Universitätsklinikum	Ulm	Albert-Einstein-Allee 23

Sponsors (1)

Lead Sponsor	Collaborator
Association of Urologic Oncology (AUO)

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Albers P, Wiegel T, Schmidberger H, Bussar-Maatz R, Härter M, Kristiansen G, Martus P, Meisner C, Wellek S, Grozinger K, Renner P, Burmester M, Schneider F, Stöckle M. Termination rates and histological reclassification of active surveillance patients wit — View Citation

Wiegel T, Albers P, Bartkowiak D, Bussar-Maatz R, Härter M, Kristiansen G, Martus P, Wellek S, Schmidberger H, Grozinger K, Renner P, Schneider F, Burmester M, Stöckle M. Results of a randomized trial of treatment modalities in patients with low or early- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer-specific survival		minimal observation time of 13 years for last study patient
Secondary	- Overall survival		minimal observation time of 13 years for last study patient
Secondary	- Time to onset of hormone therapy		17 years
Secondary	- Occurrence of the first progression on hormone therapy		17 years
Secondary	- 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
Secondary	- Complications / Safety		median 15 years