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

Sponsor
Association of Urologic Oncology (AUO) (Other)
Overall Status
Terminated
CT.gov ID
NCT01717677
Collaborator
(none)
457
Enrollment
2
Locations
4
Arms
66.9
Duration (Months)
228.5
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: radical prostatectomy
  • Radiation: percutaneous radiation therapy
  • Radiation: permanent seed implantation
  • Procedure: Active Surveillance
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
457 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Jan 31, 2018
Actual Study Completion Date :
Apr 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: radical prostatectomy

Procedure/Surgery: radical prostatectomy

Procedure: radical prostatectomy
Experimental: percutaneous radiation therapy

Radiation: percutaneous radiation therapy

Radiation: percutaneous radiation therapy
Experimental: permanent seed implantation

Radiation: permanent seed implantation

Radiation: permanent seed implantation
Experimental: Active Surveillance

Procedure/Surgery: Active Surveillance

Procedure: Active Surveillance

Outcome Measures

Primary Outcome Measures

  1. Prostate cancer-specific survival [minimal observation time of 13 years for last study patient]

Secondary Outcome Measures

  1. - Overall survival [minimal observation time of 13 years for last study patient]

  2. - Time to onset of hormone therapy [17 years]

  3. - Occurrence of the first progression on hormone therapy [17 years]

  4. - 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]

  5. - Complications / Safety [median 15 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Ulm Albert-Einstein-Allee 23 Germany 89081
2 Universitätsklinikum Homburg/Saar Kirrberger Straße Germany 66424

Sponsors and Collaborators

  • Association of Urologic Oncology (AUO)

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Association of Urologic Oncology (AUO)
ClinicalTrials.gov Identifier:
NCT01717677
Other Study ID Numbers:
  • AP 65/11
  • DRKS00004405
First Posted:
Oct 30, 2012
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Feb 10, 2021