An observational study in Prostatic Neoplasms and Metastatic Hormone-sensitive Prostate Cancer, sponsored by Janssen Cilag S.A.S.. Recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Cilag S.A.S. (part of Johnson & Johnson) · Observational
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Among 88 studies in Prostatic Neoplasms by Johnson & Johnson — 9 open to participants now, 23 under way, 9 of them phase 3. Prostatic Neoplasms · Johnson & Johnson.
Among the 88 studies in Prostatic Neoplasms by Johnson & Johnson, this one is the 5th largest by planned enrollment of the 16 observational ones that give a count, is one of 3 that started in 2025, is one of 16 observational ones, reaches primary completion later than 17 of the 22 other live ones, and was the 85th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →9 of the 88 studies in Prostatic Neoplasms by Johnson & Johnson are open now, in 8 countries. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in United States, Israel
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, Australia, China and 1 more country
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, Israel
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, United Kingdom
Ages 18+
Janssen Research & Development, LLC · Sites in United States, United Kingdom
Ages 18+ · Men only
By country, each count listing its studies:
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.
88 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 31 · Phase 2 24 · Phase 3 15 · Phase 4 2
First in 1995; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 540 is above the median of 200 across 1,309 observational studies indexed under Prostatic Neoplasms.
Median enrollment 82 across the 68 interventional studies, 300 across the 16 observational. Of the 58 that completed or were terminated, 24 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Janssen Cilag S.A.S., one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
9 of the studies in Prostatic Neoplasms by Johnson & Johnson that are under way reach primary completion within a year, 2 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 |
| 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 |
| NCT04644770Janssen Research & Development, LLCA Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer | 2026-12-08 |
| NCT04662580Janssen Research & Development, LLCARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer | 2026-12-31 |
| NCT07319871Janssen Research & Development, LLCA Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer | 2027-01-07 |
Add all 9 to your calendar (.ics) → With an account.
Among the 88 studies in Prostatic Neoplasms by Johnson & Johnson, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer (mHSPC) participants treated with apalutamide during the first year of continued treatment.
Adult male (according to their chromosomal composition at birth) participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide (Month 0) in routine clinical practice and will be followed up until 12 months after end of study visit (Month 12). No intervention will be administered as a part of this study.
Percentage of Participants With Adherence to Apalutamide at 12 Months
Adherent participants are defined as participants adherent to apalutamide at every visit until 12 months according to the Medication Adherence Report Scale (MARS-5). MARS-5 is a well-known participant-reported adherence measure (PRAM) consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
Time frame: At 12 months
Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation
Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
Time frame: At 12 months
Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status
Clinical risk factors for treatment the Eastern Cooperative Oncology Group (ECOG) will be reported.
Time frame: Up to 12 months
Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities
Clinical risk factors for treatment prostate comorbidities will be reported.
Time frame: Up to 12 months
Clinical Factors of Adherence at 12 Months: Disease Volume
Predictive clinical factors of adherence that is disease volume at 12 months will be reported.
Time frame: At 12 months
Percentage of Adherent Participants at 3, 6, and 9 Months
Percentage of adherent participants at 3 months, 6 months and 9 months according to the MARS-5 will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication. Participants are asked to evaluate how often they adopt each behavior with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
Time frame: At 3,6,9 months
Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation at 3, 6 and 9 Months
Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
Time frame: At 3, 6 and 9 months
Number of Participants with Risk of Non-Adherence as per Social, Psychological, Usage and Rational (SPUR) Factors as per SPUR Adherence Tool
SPUR is a validated, participant-reported questionnaire that assesses adherence-related behavior across thirteen specific behavioral drivers categorized into four dimensions: Social, Psychological, Usage, and Rational. It consists of 24 items and uses a 5-point Likert scale for each item (ranging from "strongly disagree" to "strongly agree"), with some items reverse-coded to minimize response bias. Scores are calculated for each behavioral driver dimension and score indicating the risk of non-adherence is calculated from them, allowing assessment of global non-adherence risk as well as analysis of the behavioral constituents of that risk by considering the mix of drivers present and their relative importance. Here, higher scores indicate more adherence.
Time frame: Baseline, Months 3, 6, 9 and 12
Spearman Correlation Coefficients at Baseline and Month 12
Spearman correlation coefficients between each of the 13 behavioral drivers will be reported.
Time frame: At Baseline and Month 12
SPUR Global Risk Score at Baseline and Month 12
SPUR is a validated, participant-reported questionnaire that assesses adherence-related behavior across thirteen specific behavioral drivers categorized into four dimensions: Social, Psychological, Usage, and Rational. It consists of 24 items and uses a 5-point Likert scale for each item (ranging from "strongly disagree" to "strongly agree"), with some items reverse-coded to minimize response bias. Scores are calculated for each behavioral driver dimension and score indicating the risk of non-adherence is calculated from them, allowing assessment of global non-adherence risk as well as analysis of the behavioral constituents of that risk by considering the mix of drivers present and their relative importance. Here, higher scores indicate more adherence.
Time frame: At Baseline and Month 12
Functional Assessment of Cancer Therapy- Prostate (FACT-P) Score
The FACT-P questionnaire is used to assess quality of life (QoL) in men undergoing therapy for prostate cancer. It is composed of 39 items using a 5-point Likert-like scale. Each item is rated on a 0 to 4, and then combined to produce subscale scores, as well as a global QoL score. Higher scores represent better QoL.
Time frame: At Baseline, Months 3, 6, 9, 12
Change from Baseline in FACT-P Score at 3, 6 and 9 Months
The FACT-P questionnaire is used to assess quality of life in men undergoing therapy for prostate cancer. It is composed of 39 items using a 5-point Likert-like scale. Each item is rated on a 0 to 4 , and then combined to produce subscale scores, as well as a global QoL score. Higher scores represent better QoL.
Time frame: Baseline, Months 3, 6, 9, 12
Demographics Characteristics of Participants: Age
The demographic characteristics of participants that is, age will be reported.
Time frame: Baseline
Demographics Characteristics of Participants: Socio-Professional Category
The demographic characteristics of participants that is, socio-professional category (the participant's last occupation held prior to retirement: Managerial \[higher managerial or lower managerial\], Non-managerial \[intermediate or small employers or lower supervisory or semi-routine or routine\], Never worked or long-term unemployed will be reported.
Time frame: Baseline
Demographics Characteristics of Participants: G8 Geriatric Screening Score
The demographic characteristics of participants that is, G8 geriatric screening score will be reported. The G8 consists of eight items: participant age (greater than \[\>\]85, 80-85, less than \[\<\]80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with higher scores indicating a lower risk of impairments.
Time frame: Baseline
Prostate-Specific Antigen (PSA) Level at Androgen-Deprivation Therapy (ADT) Initiation
PSA levels at ADT initiation will be reported.
Time frame: Up to 12 months
PSA Level at Baseline
PSA levels at baseline will be reported.
Time frame: At Baseline
Change from Baseline in PSA Levels
Change from baseline in PSA levels will be reported.
Time frame: Baseline up to 12 months
Serum Testosterone at Baseline
Serum testosterone levels will be reported.
Time frame: At baseline
Time from Initial Diagnosis of Prostate Cancer to Metastatic Stage
Time from initial diagnosis of prostate cancer to metastatic stage for metachronous participants will be reported.
Time frame: Baseline up to 12 months
Type of Imaging Methods Used for Cancer Diagnostics
Number of participants with different type of imaging methods used for cancer diagnostic (for example, magnetic resonance imaging \[MRI\], Prostate Specific Membrane Antigen Positron Emission Tomography \[PSMA-PET\], Positron emission tomography \[PET\] choline, Computed Tomography scan \[CT scan\], bone scan) will be reported.
Time frame: Baseline
Osteodensitometry Score
Osteodensitometry score, a type of imaging method used for cancer diagnostic will be reported.
Time frame: Baseline
Tumor assessment: Location of Metastases
Location of metastases as assessed by bone and CT/MRI scans, PSMA-PET scans and any other imaging methods documented in routine practice will be recorded.
Time frame: Baseline
Tumor assessment: Number of Lesions
Number of lesions as assessed by bone and CT/MRI scans, PSMA-PET scans and any other imaging methods documented in routine practice will be recorded.
Time frame: Baseline
ECOG Performance Status
ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.
Time frame: At Baseline
Number of Participants with History of Treatment for Prostate Cancer
Participants with history of treatment for prostate cancer will be reported.
Time frame: Baseline
Number of Participants Reporting Concomitant Diseases
Participants with Current concomitant diseases (co-morbidities) will be reported.
Time frame: Baseline
Number of Participants With Vital Sign Assessments
Participants with relevant vital sign assessment (blood pressure and pulse) will be reported.
Time frame: Baseline
Time from Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Diagnosis to Treatment Initiation
Time from mHSPC diagnosis to treatment initiation is defined as the time between date of mHSPC diagnosis and first administration of apalutamide.
Time frame: Baseline up to 12 months
Percentage of Participants Reaching Undetectable PSA
Percentage of participants with undetectable PSA levels that is PSA level less than or equal to (\<=) 0.2 nanogram per milliliter (ng/mL) will be reported.
Time frame: At Months 3,6,9,12
Percentage of Participants Reaching Ultralow (UL) PSA
Percentage of participants with ultralow PSA levels that is PSA level \<= 0.02 ng/mL will be reported.
Time frame: At Months 3,6,9,12
Time to Undetectable PSA
Time to undetectable PSA is defined as the time between first administration of apalutamide and date of undetectable PSA.
Time frame: Up to 12 months
Time to UL PSA
Time to UL PSA is defined as the time between first administration of apalutamide and date of UL PSA.
Time frame: Up to 12 months
Number of Participants with Greater Than or Equal to (>=) 50% Decline in PSA Values (PSA 50) from Baseline
Participants with \>=50% reduction in PSA value from baseline will be reported.
Time frame: Baseline up to 12 months
Number of Participants with >= 90% Decline in PSA Values (PSA 90) from Baseline
Participants with \>=90% reduction in PSA value from baseline will be reported.
Time frame: Baseline up to 12 months
Number of Participants with Decrease in PSA Levels (PSA Halving-time)
Participants with decrease in PSA levels (PSA halving-time) over time will be reported.
Time frame: Up to 12 months
Progression-Free Survival (PFS)
PFS is defined as the time from initiation of apalutamide until earliest record of disease progression determined by physician's assessment, or death.
Time frame: At Months 3,6,9,12
Number of Deaths
The number of deaths at months 3,6,9 and 12 will be reported.
Time frame: At Months 3,6,9,12
Number of Participants Reporting Change Since Baseline in Apalutamide and ADT Modalities
Participants reporting changes since baseline in Apalutamide and ADT Modalities (that is, dose, route of administration, number of tablets, time of intake) will be reported.
Time frame: At Baseline, Months 3,6,9,12
Time from mHSPC Diagnosis to ADT Treatment Initiation
Time from mHSPC diagnosis to ADT treatment initiation will be reported.
Time frame: Baseline up to Month 12
Time Between ADT and Apalutamide Treatment Initiation
Time between ADT and apalutamide initiation will be reported.
Time frame: Baseline up to Month 12
Number of Participants with Apalutamide Treatment Discontinuation
Participants who have discontinued apalutamide treatment will be reported.
Time frame: At Months 3,6,9,12
Reasons for Discontinuation of Apalutamide Treatment
Participants who have discontinued apalutamide treatment and the reasons for discontinuation will be reported.
Time frame: At Months 3,6,9,12
Time to Discontinuation of Apalutamide Treatment
Time to discontinuation of apalutamide treatment will be reported.
Time frame: At Months 3,6,9,12
Number of Participants Receiving Planned Subsequent Treatment for Prostate Cancer
Participants receiving planned subsequent treatment for prostate cancer will be reported.
Time frame: At Months 3,6,9,12
Percentage of Participants who Consulted for Treatment
The percentage of participants who consulted for treatment will be reported.
Time frame: At Months 3,6,9,12
Percentage of Participants who Used Caregiver Support
Percentage of participants who use caregiver support will be reported.
Time frame: At Months 3,6,9,12
Number of Participants Receiving Concomitant Treatments
Participants receiving concomitant treatments will be reported.
Time frame: At Baseline, Months 3,6,9,12
Number of Participants with a Change in Concomitant Treatments
Participants with a change in concomitant treatments will be reported.
Time frame: At Months 3,6,9,12
Number of Participants Experiencing At Least One Adverse Event (AE)
An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. A serious adverse event is any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product or is medically important. Severity of AEs will be graded as follows: Mild (Easily tolerated symptoms), Moderate (Sufficient discomfort, causes interference with normal activity) and Severe (Extreme distress).
Time frame: At Months 3,6,9,12
Percentage of Undetectable PSA According to Adherence Levels
Percentage of undetectable PSA according to adherence levels, that is PSA level \<= 0.2 ng/mL will be reported.
Time frame: At Months 3,6,9,12
Percentage of UL PSA According to Adherence Levels
Percentage of UL PSA according to adherence levels, that is PSA level \<= 0.02 ng/mL will be reported.
Time frame: At Months 3,6,9,12
Number of Participants with PSA 50 Response According to Adherence Levels
Participants with \>=50% reduction in PSA value from baseline according to adherence levels will be reported.
Time frame: At Months 3,6,9, and 12
Number of Participants with PSA 90 Response According to Adherence Levels
Participants with \>=90% reduction in PSA value from baseline according to adherence levels will be reported.
Time frame: At Months 3,6,9, and 12
Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Concomitant Treatments
Participants using the concomitant treatments will be reported.
Time frame: Up to 12 months
Clinical Risk Factor Among Adherent and Non-adherent Participants: Prostate Specific Antigen (PSA) Rate
Clinical risk factors for prostate specific antigen (PSA) rate will be reported.
Time frame: Up to 12 months
Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Socio-professional Category
Participants with socio-professional category will be reported.
Time frame: Up to 12 months
Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Disease Specialized Consultations
Participants reporting the use of disease specialized consultations will be reported.
Time frame: Up to 12 months
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
Of 109 industry-sponsored observational studies under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's planned 24 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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