Metastatic Castration Resistant Prostate CancerNCT06517719
Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 38 sites in Germany.
Trial summary
The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- lutetium (177Lu) vipivotide tetraxetan
- How many people
- 500 participants
- Where
- 38 sitesGermany
- Study dates
- 4 Sep 2024to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patients with mCRPC
Who may be able to join
- All patients must meet the following inclusion criteria during the identification period:
- Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
- ≥ 18 years old at the time of enrollment
- Written informed consent must be obtained prior to any data collection
- Willing to participate in Quality of Life post treatment date collection for 1 year
Who cannot join
- Patients must not meet the following exclusion criterion during the identification period:
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
38 sites in 1 country
Germany38 sites, 38 recruiting
- Recruiting
Novartis Investigative Site
Aachen, 52074
- Recruiting
Novartis Investigative Site
Augsburg, 86179
- Recruiting
Novartis Investigative Site
Berlin, 10249
- Recruiting
Novartis Investigative Site
Berlin, 12559
- Recruiting
Novartis Investigative Site
Berlin, 13125
- Recruiting
Novartis Investigative Site
Bielefeld, 33611
- Recruiting
Novartis Investigative Site
Bonn, 53105
- Recruiting
Novartis Investigative Site
Braunschweig, 38114
- Recruiting
Novartis Investigative Site
Chemnitz, 09113
- Recruiting
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
- Recruiting
Novartis Investigative Site
Cottbus, Brandenburg, 03048
- Recruiting
Novartis Investigative Site
Dortmund, 44137
- Recruiting
Novartis Investigative Site
Dortmund, 44309
- Recruiting
Novartis Investigative Site
Dresden, Saxony, 01307
- Recruiting
Novartis Investigative Site
Erfurt, 99089
- Recruiting
Novartis Investigative Site
Erlangen, 91054
- Recruiting
Novartis Investigative Site
Essen, 45147
- Recruiting
Novartis Investigative Site
Frankfurt (Oder), Brandenburg, 15236
- Recruiting
Novartis Investigative Site
Fulda, 36043
- Recruiting
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120
- Recruiting
Novartis Investigative Site
Herford, 32049
- Recruiting
Novartis Investigative Site
Homburg, 66421
- Recruiting
Novartis Investigative Site
Jena, Thuringia, 07740
- Recruiting
Novartis Investigative Site
Konstanz, Baden-Wurttemberg, 78464
- Recruiting
Novartis Investigative Site
Leipzig, Saxony, 04103
- Recruiting
Novartis Investigative Site
Ludwigshafen, Germany, 67063
- Recruiting
Novartis Investigative Site
Magdeburg, 39120
- Recruiting
Novartis Investigative Site
Mainz, 55131
- Recruiting
Novartis Investigative Site
Marburg, Hesse, 35043
- Recruiting
Novartis Investigative Site
Munich, Bavaria, 81377
- Recruiting
Novartis Investigative Site
Nuremberg, 90419
- Recruiting
Novartis Investigative Site
Regensburg, Bavaria, 93053
- Recruiting
Novartis Investigative Site
Rostock, 18057
- Recruiting
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, 70174
- Recruiting
Novartis Investigative Site
Trier, 54290
- Recruiting
Novartis Investigative Site
Tübingen, 72076
- Recruiting
Novartis Investigative Site
Ulm, 89081
- Recruiting
Novartis Investigative Site
Würzburg, Bavaria, 97080
About this study
Official title: Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study
The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.
Read the detailed description
This non-interventional observational, prospective cohort study is using primary data collection to describe the routine clinical practice and HRQoL of patients with Metastatic castration-resistant prostate cancer (mCRPC) initiating lutetium (177Lu) vipivotide tetraxetan using patient questionnaires.
Data will be collected at the following time points: pre-index (if patient is eligible), index date (first application of lutetium (177Lu) vipivotide tetraxetan), during treatment, at EoT, and during follow-up.
The duration of a treatment cycle is 6 weeks (± 1 week). Patients will be treated for up to 6 cycles (as per local label).
EoT visit / assessments will be performed after the last lutetium (177Lu) vipivotide tetraxetan application.
Follow-up period: patient data will be collected if available up to 1 year after EoT.
- Being tested
- lutetium (177Lu) vipivotide tetraxetan
- Keywords
- metastatic castration resistant prostate cancer, mCRPC, Prostate cancer, lutetium vipivotide tetraxetan, 177Lu
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lutetium (177Lu) vipivotide tetraxetanOther
This is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Lutetium (177Lu) vipivotide tetraxetan | Patients with mCRPC initiating lutetium (177Lu) vipivotide tetraxetan Receives: Other: lutetium (177Lu) vipivotide tetraxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
Measured: Baseline, up to 1 year after end of treatment
Change from baseline in FACT-P
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
Measured: Baseline, up to 1 year after end of treatment
Functional Assessment of Cancer Therapy-Radionuclid Therapy (FACT-RNT)
The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies.
The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
Measured: Baseline, up to 1 year after end of treatment
Change from baseline in FACT-RNT
The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies.
The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
Measured: Baseline, up to 1 year after end of treatment
Brief Pain Inventory-Short Form (BPI-SF)
The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use
Measured: Baseline, up to 1 year after end of treatment
Change from baseline in BPI-SF
The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use
Measured: Baseline, up to 1 year after end of treatment
Radiographic progression
Radiographic progression is measured with radiographic imaging (e.g. CT with contrast/MRI, bone scan, PET/CT, SPECT/CT) according to RECIST/PCWG3
Measured: Up to 1 year after end of treatment
Clinical progression
Unequivocal clinical progression (UCP) is considered a worsening of clinical status with or without radiographic progression (RAD): escalation in cancer related-pain, immediate need for initiation of new anticancer treatment, surgical, or radiological intervention, deterioration in ECOG to grade 3 or higher, in the opinion of investigator
Measured: Up to 1 year after end of treatment
Time to prostate-specific antigen (PSA) progression
Time to PSA progression is defined as time from randomization to first PSA progression.
PSA progression is defined as the date that a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir or baseline is documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks will be ignored in the absence of other evidence of disease progression (adapted from Prostate Cancer Working Group (PCWG3) Guidance).
Measured: Up to 1 year after end of treatment
Prostate-specific antigen (PSA) 30/50/90
Response rates are defined as the proportion of patients who have a ≥30%/50%/90% decrease in PSA from baseline that is confirmed by a second PSA measurement.
Measured: Up to 1 year after end of treatment
Progression-free survival (PFS)
PFS, defined as the time from initial treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to 1 year after end of treatment
Progression-free survival 2 (PFS2)
PFS2, defined as time from initial treatment to the first documented disease progression or death under the treatment after lutetium (177Lu) vipivotide tetraxetan.
Measured: Up to 1 year after end of treatment
Overall Survival (OS)
OS defined as the time from initial treatment until death from any cause.
Measured: Up to 1 year after end of treatment
Time to initiation of pain medication
Time to initiation of pain medication is defined as time from index date to the first use of any pain medication or progression.
Measured: Up to 1 year after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start4 Sep 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517719
- Sponsor's protocol ID
- CAAA617A1DE04
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06517719
- Acronym / sponsor ID
- CAAA617A1DE04
- Keywords
- metastatic castration resistant prostate cancer, mCRPC, Prostate cancer, lutetium vipivotide tetraxetan, 177Lu
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- 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.
The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.
Detailed description
This non-interventional observational, prospective cohort study is using primary data collection to describe the routine clinical practice and HRQoL of patients with Metastatic castration-resistant prostate cancer (mCRPC) initiating lutetium (177Lu) vipivotide tetraxetan using patient questionnaires.
Data will be collected at the following time points: pre-index (if patient is eligible), index date (first application of lutetium (177Lu) vipivotide tetraxetan), during treatment, at EoT, and during follow-up.
The duration of a treatment cycle is 6 weeks (± 1 week). Patients will be treated for up to 6 cycles (as per local label).
EoT visit / assessments will be performed after the last lutetium (177Lu) vipivotide tetraxetan application.
Follow-up period: patient data will be collected if available up to 1 year after EoT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutetium (177Lu) vipivotide tetraxetan | – | Other: lutetium (177Lu) vipivotide tetraxetanPatients with mCRPC initiating lutetium (177Lu) vipivotide tetraxetan |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients with mCRPC
Key inclusion criteria (5 listed)
- Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
- ≥ 18 years old at the time of enrollment
- Written informed consent must be obtained prior to any data collection
- Willing to participate in Quality of Life post treatment date collection for 1 year
Key exclusion criteria (2 listed)
- Patients must not meet the following exclusion criterion during the identification period:
- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan
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 |
|---|---|---|
| lutetium (177Lu) vipivotide tetraxetanThis is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement. | Other | Lutetium (177Lu) vipivotide tetraxetan |
Primary outcome
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Time frame: Baseline, up to 1 year after end of treatment
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
Change from baseline in FACT-P
Time frame: Baseline, up to 1 year after end of treatment
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
Functional Assessment of Cancer Therapy-Radionuclid Therapy (FACT-RNT)
Time frame: Baseline, up to 1 year after end of treatment
The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies. The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
Change from baseline in FACT-RNT
Time frame: Baseline, up to 1 year after end of treatment
The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies. The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
Brief Pain Inventory-Short Form (BPI-SF)
Time frame: Baseline, up to 1 year after end of treatment
The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use
Change from baseline in BPI-SF
Time frame: Baseline, up to 1 year after end of treatment
The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use
Radiographic progression
Time frame: Up to 1 year after end of treatment
Radiographic progression is measured with radiographic imaging (e.g. CT with contrast/MRI, bone scan, PET/CT, SPECT/CT) according to RECIST/PCWG3
Clinical progression
Time frame: Up to 1 year after end of treatment
Unequivocal clinical progression (UCP) is considered a worsening of clinical status with or without radiographic progression (RAD): escalation in cancer related-pain, immediate need for initiation of new anticancer treatment, surgical, or radiological intervention, deterioration in ECOG to grade 3 or higher, in the opinion of investigator
Time to prostate-specific antigen (PSA) progression
Time frame: Up to 1 year after end of treatment
Time to PSA progression is defined as time from randomization to first PSA progression. PSA progression is defined as the date that a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir or baseline is documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks will be ignored in the absence of other evidence of disease progression (adapted from Prostate Cancer Working Group (PCWG3) Guidance).
Prostate-specific antigen (PSA) 30/50/90
Time frame: Up to 1 year after end of treatment
Response rates are defined as the proportion of patients who have a ≥30%/50%/90% decrease in PSA from baseline that is confirmed by a second PSA measurement.
Progression-free survival (PFS)
Time frame: Up to 1 year after end of treatment
PFS, defined as the time from initial treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Progression-free survival 2 (PFS2)
Time frame: Up to 1 year after end of treatment
PFS2, defined as time from initial treatment to the first documented disease progression or death under the treatment after lutetium (177Lu) vipivotide tetraxetan.
Overall Survival (OS)
Time frame: Up to 1 year after end of treatment
OS defined as the time from initial treatment until death from any cause.
Time to initiation of pain medication
Time frame: Up to 1 year after end of treatment
Time to initiation of pain medication is defined as time from index date to the first use of any pain medication or progression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 38 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - Prostate (FACT-P) (time frame: Baseline, up to 1 year after end of treatment). The study lists 14 primary outcomes in all. 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 13 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.