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

Association of Urologic Oncology (AUO)

Status: Terminated

Conditions: Prostate Cancer

Treatments: Procedure: Active Surveillance; Procedure: radical prostatectomy; Radiation: permanent seed implantation; Radiation: percutaneous radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01717677

AP 65/11

DRKS00004405 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 457 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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457 participants in 4 patient groups

radical prostatectomy

Experimental group

Description:

Procedure/Surgery: radical prostatectomy

Treatment:

Procedure: radical prostatectomy

percutaneous radiation therapy

Experimental group

Description:

Radiation: percutaneous radiation therapy

Treatment:

Radiation: percutaneous radiation therapy

permanent seed implantation

Experimental group

Description:

Radiation: permanent seed implantation

Treatment:

Radiation: permanent seed implantation

Active Surveillance

Experimental group

Description:

Procedure/Surgery: Active Surveillance

Treatment:

Procedure: Active Surveillance