Prostate CancerProtoChoicePNCT02766686
Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons
A study testing Radiotherapy with protons and Radiotherapy with photons in people with Prostate Cancer, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or higher) by the use of… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiotherapy with protons and Radiotherapy with photons
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2016to 23 Aug 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- life expectancy ≥ 10 years
- adenocarcinoma of the prostate confirmed by punch biopsy
- locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. T1-3b N0-1 M0
- stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months)
- good general condition (ECOG performance status 0 - 1)
- marker seed implantation before irradiation (optional) or possibility of Image-guided Radiation Therapy (IGRT) by CT
- adequate compliance for follow-up
- written informed consent
Who cannot join
- distant metastases
- previous radiotherapy of the lesser pelvis
- previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer
- participation in another clinical study, if it's excluded by the study protocols
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
Dresden, 01307
Klinikum rechts der Isar, Technische Universität München
Munich, 81675
Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen
Tübingen, 72076
About this study
Official title: Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain assessment of quality of life, biochemical recurrence and recurrence free survival as well as overall survival and economic comparison between photon and proton therapy.
Read the detailed description
The hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. With an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. With an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. As randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. Stratification criteria will include: Age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. Comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy with protons, Radiotherapy with photons
- Keywords
- Prostate cancer, proton radiotherapy, photon radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy with protonsRadiation
Radiotherapy with photonsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy with protons | Experimental | Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week Receives: Radiation: Radiotherapy with protons |
| Radiotherapy with photons | Active comparator | Photon-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week Receives: Radiation: Radiotherapy with photons |
| Radiotherapy with photons with lymph drainage vessels | Other | Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week Receives: Radiation: Radiotherapy with photons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of moderate/ severe side effects
≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects
Measured: after 2 years ( measured from the first day of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startSep 2016
- Primary completion28 Feb 2026
- Study completion23 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Consortium for Translational Cancer Research, National Center for Radiation Research in Oncology Dresden/Heidelberg, Radiation Oncology Working Group of the German Cancer Society
- Responsible party
- Principal investigator, Tobias Hölscher, Technische Universität Dresden
- Investigators
- Tobias Hölscher, Dr., Study chair, University Hospital C. G. Carus Dresden, Departm. of Radiation Therapy and Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766686
- Sponsor's protocol ID
- STR - ProtoChoice-P - 2015
- Acronym
- ProtoChoiceP
- Status last verified
- Aug 2026
- First submitted
- 9 May 2016
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons in Standard Fractionation and Standard Dosage
- ClinicalTrials.gov ID
- NCT02766686
- Acronym / sponsor ID
- ProtoChoiceP / STR - ProtoChoice-P - 2015
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, proton radiotherapy, photon radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Consortium for Translational Cancer Research, National Center for Radiation Research in Oncology Dresden/Heidelberg, Radiation Oncology Working Group of the German Cancer Society
- Study start
- Sep 2016
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 23 Aug 2026 (actual)
- First posted
- 10 May 2016 (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.
ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain assessment of quality of life, biochemical recurrence and recurrence free survival as well as overall survival and economic comparison between photon and proton therapy.
Detailed description
The hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. With an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. With an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. As randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. Stratification criteria will include: Age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. Comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy with protons | Experimental | Radiation: Radiotherapy with protonsProton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week |
| Radiotherapy with photons | Active comparator | Radiation: Radiotherapy with photonsPhoton-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week |
| Radiotherapy with photons with lymph drainage vessels | Other | Radiation: Radiotherapy with photonsPhoton-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- life expectancy ≥ 10 years
- adenocarcinoma of the prostate confirmed by punch biopsy
- locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. T1-3b N0-1 M0
- stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months)
- good general condition (ECOG performance status 0 - 1)
Key exclusion criteria (4 listed)
- distant metastases
- previous radiotherapy of the lesser pelvis
- previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer
- participation in another clinical study, if it's excluded by the study protocols
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 |
|---|---|---|
| Radiotherapy with protons | Radiation | Radiotherapy with protons |
| Radiotherapy with photons | Radiation | Radiotherapy with photons, Radiotherapy with photons with lymph drainage vessels |
Primary outcome
Cumulative incidence of moderate/ severe side effects
Time frame: after 2 years ( measured from the first day of treatment)
≥ grade 2 by CTCAE combined for genito-urinary and gastrointestinal side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
Tobias Hölscher, Dr. study chair
University Hospital C. G. Carus Dresden, Departm. of Radiation Therapy and Radiation Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy with protons and Radiotherapy with photons in people with Prostate Cancer, run by Technische Universität Dresden at 3 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative incidence of moderate/ severe side effects (time frame: after 2 years ( measured from the first day of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.