TerminatedNot Applicable

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

Stopped: Insufficient Recruitment

Germany457 participantsStarted 2012-10

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prostate cancer-specific survival

Timeframe: minimal observation time of 13 years for last study patient

Trial details

NCT IDNCT01717677

SponsorAssociation of Urologic Oncology (AUO)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-31

View on ClinicalTrials.gov More Prostate Cancer trials