Prostate CancerPREFERENCT01717677
Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
A study testing radical prostatectomy, percutaneous radiation therapy and permanent seed implantation in people with Prostate Cancer, run by Association of Urologic Oncology (AUO) at 2 sites in Germany.
Trial summary
4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- radical prostatectomy, percutaneous radiation therapy and permanent seed implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2012to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklinikum
Homburg/Saar, Kirrberger Straße, 66424
Universitätsklinikum
Ulm, Albert-Einstein-Allee 23, 89081
About this study
Official title: Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- radical prostatectomy, percutaneous radiation therapy, permanent seed implantation, Active Surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radical prostatectomyProcedure or surgery
percutaneous radiation therapyRadiation
permanent seed implantationRadiation
Active SurveillanceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| radical prostatectomy | Experimental | Procedure/Surgery: radical prostatectomy Receives: Procedure: radical prostatectomy |
| percutaneous radiation therapy | Experimental | Radiation: percutaneous radiation therapy Receives: Radiation: percutaneous radiation therapy |
| permanent seed implantation | Experimental | Radiation: permanent seed implantation Receives: Radiation: permanent seed implantation |
| Active Surveillance | Experimental | Procedure/Surgery: Active Surveillance Receives: Procedure: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer-specific survival
Measured: minimal observation time of 13 years for last study patient
Secondary outcomes (5)
- Overall survival
Measured: minimal observation time of 13 years for last study patient
- Time to onset of hormone therapy
Measured: 17 years
- Occurrence of the first progression on hormone therapy
Measured: 17 years
- Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
Measured: before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
- Complications / Safety
Measured: median 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion31 Jan 2018
- Study completion30 Apr 2018
Why it stopped: Insufficient Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Urologic Oncology (AUO)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Stöckle, Prof. Dr., Principal investigator, Klinik für Urologie und Kinderurologie der Universität des SaarlandesThomas Wiegel, Prof. Dr., Principal investigator, Klinik für Strahlentherapie und Radioonkologie der Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717677
- Sponsor's protocol ID
- AP 65/11
- Other IDs
- DRKS00004405
- Acronym
- PREFERE
- Status last verified
- Feb 2021
- First submitted
- 26 Oct 2012
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32189088Wiegel 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.
PubMed 32886212
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
- ClinicalTrials.gov ID
- NCT01717677
- Acronym / sponsor ID
- PREFERE / AP 65/11
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Recruitment
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Association of Urologic Oncology (AUO)University, hospital or other
- Study start
- Oct 2012
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| radical prostatectomy | Experimental | Procedure: radical prostatectomyProcedure/Surgery: radical prostatectomy |
| percutaneous radiation therapy | Experimental | Radiation: percutaneous radiation therapyRadiation: percutaneous radiation therapy |
| permanent seed implantation | Experimental | Radiation: permanent seed implantationRadiation: permanent seed implantation |
| Active Surveillance | Experimental | Procedure: Active SurveillanceProcedure/Surgery: Active Surveillance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radical prostatectomy | Procedure or surgery | radical prostatectomy |
| percutaneous radiation therapy | Radiation | percutaneous radiation therapy |
| permanent seed implantation | Radiation | permanent seed implantation |
| Active Surveillance | Procedure or surgery | Active Surveillance |
Primary outcome
Prostate cancer-specific survival
Time frame: minimal observation time of 13 years for last study patient
5 secondary outcomes
- Overall survival
Time frame: minimal observation time of 13 years for last study patient
- Time to onset of hormone therapy
Time frame: 17 years
- Occurrence of the first progression on hormone therapy
Time frame: 17 years
- Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
Time frame: before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
- Complications / Safety
Time frame: median 15 years
Results and safety
The study was stopped early (reason given: Insufficient Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Results publication: PubMed 32189088Albers 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.
- Results publication: PubMed 32886212Wiegel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stöckle, Prof. Dr. principal investigator
Klinik für Urologie und Kinderurologie der Universität des Saarlandes
Thomas Wiegel, Prof. Dr. principal investigator
Klinik für Strahlentherapie und Radioonkologie der Universität Ulm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radical prostatectomy, percutaneous radiation therapy and permanent seed implantation in people with Prostate Cancer, run by Association of Urologic Oncology (AUO) at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer-specific survival (time frame: minimal observation time of 13 years for last study patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.