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

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Radiation: percutaneous radiation therapy; Procedure: Active Surveillance; Procedure: radical prostatectomy; Radiation: permanent seed implantation

• Registration Number: NCT01717677
• Lead Sponsor: Association of Urologic Oncology (AUO)

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2018-01-31
• Study Completion: 2018-04-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 457

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous radiation therapy	percutaneous radiation therapy	Radiation: percutaneous radiation therapy
Active Surveillance	Active Surveillance	Procedure/Surgery: Active Surveillance
radical prostatectomy	radical prostatectomy	Procedure/Surgery: radical prostatectomy
permanent seed implantation	permanent seed implantation	Radiation: permanent seed implantation

Primary Outcome Measures

Name	Time	Method
Prostate cancer-specific survival	minimal observation time of 13 years for last study patient

Secondary Outcome Measures

Name	Time	Method
- Complications / Safety	median 15 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
- Overall survival	minimal observation time of 13 years for last study patient
- Time to onset of hormone therapy	17 years

Trial Locations

Locations (1)

Universitätsklinikum; 🇩🇪 Homburg/Saar, Kirrberger Straße, Germany