Clinical trial NCT01717677: Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Official title: Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Association of Urologic Oncology (AUO)
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 457
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prostate cancer-specific survival
timeFrame: minimal observation time of 13 years for last study patient
Secondary outcomes:
measure: - Overall survival
timeFrame: minimal observation time of 13 years for last study patient
measure: - Time to onset of hormone therapy
timeFrame: 17 years
measure: - Occurrence of the first progression on hormone therapy
timeFrame: 17 years
measure: - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
timeFrame: before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
measure: - Complications / Safety
timeFrame: median 15 years
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum
state: Albert-Einstein-Allee 23
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum
state: Kirrberger Straße
Study officials:
affiliation: Klinik für Urologie und Kinderurologie der Universität des Saarlandes
name: Michael Stöckle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Strahlentherapie und Radioonkologie der Universität Ulm
name: Thomas Wiegel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.