An observational study in Localized Prostate Carcinoma, Prostate Cancer (Adenocarcinoma) and Prostate Hyperplasia, sponsored by University of Zurich. Recruiting at 3 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Zurich · Observational
Among 332 studies in Prostatic Neoplasms with a site in Germany — 70 open to participants now, 116 under way, 36 of them phase 3. Prostatic Neoplasms · Germany.
Among the 332 studies in Prostatic Neoplasms with a site in Germany, this one is the 54th largest by planned enrollment of the 61 observational ones that give a count, is one of 24 that started in 2024, is one of 61 observational ones, reaches primary completion later than 32 of the 115 other live ones, and was the 292nd registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →70 of the 332 studies in Prostatic Neoplasms with a site in Germany are open now. Recruiting first, the newest first:
University Hospital Tuebingen · Sites in Germany
Ages 18–80 · Men only
AstraZeneca · Sites in Germany, United States, Austria and 18 more countries
Ages 18+ · Men only
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD · Sites in Germany, France, Italy and 2 more countries
Ages 18+ · Men only
AstraZeneca · Sites in Germany, United States, Australia and 4 more countries
Ages 18–99 · Men only
Novartis Pharmaceuticals · Sites in Germany, United States, Australia and 5 more countries
Ages 18+ · Men only
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
332 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 34 · Phase 2 71 · Phase 3 113 · Phase 4 9
First in 1995; this study’s year is marked. 24 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 75 is below the median of 200 across 1,309 observational studies indexed under Prostatic Neoplasms.
Median enrollment 279 across the 268 interventional studies, 461 across the 61 observational. Of the 199 that completed or were terminated, 93 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
217 of 332 have an industry lead sponsor. The 10 most frequent:
University of Zurich is the lead sponsor of 1,050 studies on the registry; 134 are open to participants now.
University of Zurich has 9 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
27 of the studies in Prostatic Neoplasms with a site in Germany that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06551324Phase 3PfizerA Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). | 2027-02-28 |
| NCT06122584Phase 3ABX advanced biochemical compounds GmbHDiagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer | 2027-03 |
| NCT02531516Phase 3Aragon Pharmaceuticals, Inc.An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | 2027-03-01 |
| NCT05794906Phase 3BayerA Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies | 2027-07-30 |
Add all 27 to your calendar (.ics) → With an account.
Among the 332 studies in Prostatic Neoplasms with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and/or prostatic hyperplasia.
Background: Stereotactic body radiotherapy (SBRT) for localized prostate cancer has demonstrated non-inferior oncological outcomes and toxicity profiles to conventionally or moderately hypofractioned radiotherapy regimens, while offering the advantage of shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia.
Methods: This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image-guided (MRI) online adaptive SBRT in patients with intermediate to (very) high-risk localized prostate cancer who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume >60 mL). The primary outcome measure is urogenital toxicity grade ≥3 within 3 months after completion of SBRT (according to CTCAE V5.0 and RTOG) or discontinuation of therapy. Our aim is to show that the event rate is at 3% below a clinically acceptable threshold, which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. In our validation cohort we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75.
This international multicenter prospective phase II study, conducted in collaboration with several academic hospitals in Switzerland and Germany, will include patients with histologically confirmed intermediate to (very) high risk localized prostate cancer with lower urinary tract symptoms and/or prostate hyperplasia. These patients are planned to receive weekly CT or MRI online adaptive SBRT for localized prostate cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For our pilot study, we assumed that around 3% of patients would have grade 3 acute urogenital toxicity (i.e. 1 patient). The rate of treatment discontinuation within 3 months was considered negligible. Our aim was to show with high probability, that the event rate was below a clinically acceptable threshold, which was set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. Dropouts prior to treatment start will be replaced.
Radiation: radiotherapy
For our validation study, we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75. Dropouts prior to treatment start will be replaced.
Radiation: radiotherapy
Patients with prostate cancer in the medium or high risk range who are planned to receive definitive CT or MRI-adaptive SBRT.
acute grade ≥ III urogenital toxicity
The primary endpoint is acute grade ≥ III urogenital toxicity ≤3 months after completion of radiotherapy (according to the NCI CTCAE V5 or RTOG) or treatment discontinuation related to treatment.
Time frame: ≤ 3 months after completion of radiotherapy
Gastrointestinal toxicity of grade ≥3
Gastrointestinal toxicity of grade ≥3 within 3 months after completion of radiotherapy (according to CTCAE V5.0 and RTOG)
Time frame: ≤ 3 months after completion of radiotherapy
Mortality
Mortality (related to treatment and/or disease).
Time frame: ≤1 year after initiation of radiotherapy
Urogenital and gastrointestinal toxicities
Number of urogenital and gastrointestinal toxicities within 5 years after completion of radiotherapy and their severity.
Time frame: ≤ 5 years after completion of radiotherapy
Biochemical progression-free survival
Biochemical progression-free survival (determined from the start of therapy until the occurrence of PSA recurrence according to the Phoenix criteria i.e. post- therapeutic PSA nadir + 2 ng/ml),
Time frame: ≤ 5 years after completion of radiotherapy
Hormonal therapy-free survival
Hormonal therapy-free survival (determined from the start of therapy until the start of hormonal therapy,
Time frame: ≤ 5 years after completion of radiotherapy
Overall survival
overall survival (defined from the start of therapy until death or censoring)
Time frame: 5 years after completion of radiotherapy
Quality-of-life questionnaire C-30 from the European Organisation for Research and Treatment of Cancer
Quality-of-life measured using the EORTC QLQ-C30 questionnaire during and after treatment All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: ≤ 5 years after completion of radiotherapy
Uroflowmetry (optional)
Uroflowmetry prior to the start of radiotherapy (optional study procedure)
Time frame: Uroflowmetry ≤ 6 weeks prior to the start of radiotherapy
Quality-of-life questionnaire PR25 of the European Organisation for Research and Treatment of Cancer
Quality-of-life measured using the QLQ-PR25 questionnaire during and after treatment All of the scales and single-item measures range in score from 0 to 100. A high score for the Sexual Activity and Sexual Functioning scales represents a high level of functioning, whereas a high score for the Urinary, Bowel, and Hormonal Treatment-Related symptoms scales and Incontinence Aid item represents a high level of symptomatology or problems.
Time frame: ≤ 5 years after completion of radiotherapy
Plan to share: Yes — Individual participant data that underlie the results reported in this trial after de-identification. Other documents may be shared include the study protocol.
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months after article publication.
Access criteria: Proposals to access study data should send request to matthias.guckenberger@usz.ch. To gain access, data requesters must sign data access agreement.
Started Mar 2024 (actual). Primary completion is estimated for Sep 2026, 30 months after the start.
Of 540 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 30 months is below that.
Counting every sponsor, half of 649 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
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