Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 ) FDA label
Also known as Apalutamide, ARN-509, Erleada
JNJ-56021927 · 16 trials · 21 indications
rPFS is defined as the duration from the date of randomization to the date of first documentation of confirmed radiographic progressive disease or death due to any cause, whichever occurs first. rPFS will be assessed by investigators using conventional imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] and 99mTc bone scans).
Severity adjusted hot flash score will be calculated from the hot flash diary which will be daily filled by the participants.
Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).
Measured by Expanded Prostate Cancer Index Composite-26 sexual domain
Measured by EPIC-26 hormonal domain
Measured by Patient Reported Outcomes Measurement Information Systems (PROMIS) Fatigue short form (SF)
ppMPFS is defined as the appearance of at least one new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.
The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function
Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.
Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.
Descriptive statistics will be used to characterize QOL over time in each arm.
pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
Will be summarized by count and percent along with the 95% confidence interval. This will then be compared to the historical control rate of 70% using a two sample z test for proportions with a one-sided p-value threshold of 0.05.
Pathological Minimal Residual Disease (pMRD): pathological minimal residual disease (pMRD) is defined as residual tumour 5mm or less.
Pathological minimal residual disease is defined as residual tumour 5 mm or less.
Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA \> 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study.
Percentage of participants maintaining testosterone level \<50 ng/dL through Day 28 were reported.
Overall response rate (ORR) was defined as the percentage of participants who achieve partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version1.1, including with either confirmed best overall response of complete response (CR) or PR during the study. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
Biochemical progression is defined as the first occurrence of the following: * A rise in PSA ≥0.2 ng/mL from nadir PSA, confirmed by a second PSA measurement equal to or higher than the first; * Clinical or radiographic local, regional, or distant metastases * Death from any cause. Biochemical progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. Arms are compared within molecular subtype group sequentially based on a study design that determines if and how to incorporate the biomarker in a in a subsequent phase III trial.
Date of randomization and date at which local treatment is initiated
The biological active and tolerable combination doses are those that satisfy observed DLT rate\<33% and demonstrate reduction in myeloid derived suppressor cells (MDSCs).
Response rate on the basis of Prostate Cancer Working Group 3 (PCWG3), and/or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
AUC(0-last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of apalutamide calculated by linear-linear trapezoidal summation.
Cmax is defined as peak observed plasma concentration of the drug.
Plasma concentration of apalutamide will be reported.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
The dose will be considered intolerable if a participants developed either any Grade 3 or 4 non-hematologic toxicity; GI toxicities such as abdominal pain, nausea, vomiting, constipation, and diarrhea, must persist at Grade 3-4 despite maximal medical therapy, Grade 4 neutropenia (that is, ANC less than \[\<\] 500 per microliter \[mcL\] for five or more consecutive days, Grade 4 thrombocytopenia (\<25,000 per mcL) or Grade 3 thrombocytopenia (greater than or equal to \[\>=\] 25,000 - \<50,000 per mcL) with a bleeding episode requiring platelet transfusion, any other Grade 4 hematologic toxicity of more than 5 days duration, any grade treatment-related seizure, the other toxicities which do not meet any of the above criteria but which, in the opinion of the Investigator, are equivalent to DLTs.
| Arm | Type | Description |
|---|---|---|
| Arm A (Intermittent ADT Group) | EXPERIMENTAL | Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first. |
| Arm B (Continuous ADT Group) | ACTIVE_COMPARATOR | Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and continue to receive apalutamide plus ADT or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first. |
| Arm I (de-intensification study) | ACTIVE_COMPARATOR | Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin, histrelin, or relugolix and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity. Patients undergo bone scan, PET scan, CT scan, and MRI at screening and as clinically indicated and may optionally undergo blood sample collection throughout the study. |
| Arm II (de-intensification study) | EXPERIMENTAL | Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin, histrelin, or relugolix and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo bone scan, PET scan, CT scan, and MRI at screening and as clinically indicated and may optionally undergo blood sample collection throughout the study. |
| Arm III (intensification study) | ACTIVE_COMPARATOR | Patients undergo RT over 2-11 weeks and receive ADT as in Arm I. Patients undergo bone scan, PET scan, CT scan, and MRI at screening and as clinically indicated and may optionally undergo blood sample collection throughout the study. |
| Arm IV (intensification study) | EXPERIMENTAL | Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin, histrelin, or relugolix) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide PO QD. Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity. Patients undergo bone scan, PET scan, CT scan, and MRI at screening and as clinically indicated and may optionally undergo blood sample collection throughout the study. |
| Interventional Cohort (Group 1): RT+ LHRHa | ACTIVE_COMPARATOR | Participants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. |
| Interventional Cohort (Group 2): RT+LHRHa + Apalutamide | EXPERIMENTAL | Participants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. Participants will also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days. |
| Observational Cohort(Group3) PSMA-PET Negative Participants | NO_INTERVENTION | Enrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician. |
| Arm A (EBRT, short-term androgen deprivation therapy [STAD]) | ACTIVE_COMPARATOR | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm B (EBRT, STAD, apalutamide) | EXPERIMENTAL | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm C (EBRT, STAD, apalutamide) | EXPERIMENTAL | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B. |
| Arm D (EBRT, STAD, apalutamide, RT) | EXPERIMENTAL | STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity. |
| Arm I (hormone therapy, radiation therapy) | ACTIVE_COMPARATOR | Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study. |
| Arm II (hormone therapy, radiation therapy, apalutamide) | EXPERIMENTAL | Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90 of each cycle. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study. |
| Apalutamide + ADT | EXPERIMENTAL | Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis. |
| Placebo + ADT | EXPERIMENTAL | Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis. |
| Treatment (apalutamide, SBRT) | EXPERIMENTAL | Patients receive apalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 or 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo SBRT for 5 fractions over 1-2 weeks beginning on day 1 of cycle 1. Patients also undergo multiparametric MRI and collection of blood samples throughout the trial. Patients undergo PSMA-PET/CT scans during screening and follow up. |
| Group 1a | ACTIVE_COMPARATOR | LHRHa plus apalutamide. |
| Group 1b | ACTIVE_COMPARATOR | LHRHa plus apalutamide plus abiraterone acetate plus prednisone. |
| Group 2a | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone. |
| Group 2b | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus docetaxel. |
| Group 3 | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus niraparib |
| Group 4 | ACTIVE_COMPARATOR | LHRHa plus apalutamide plus atezolizumab |
| Group 5 | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus tazemetostat |
| Group 6 | ACTIVE_COMPARATOR | LHRHa plus abiraterone acetate plus prednisone plus Capivasertib |
| Apalutamide + Androgen Deprivation Therapy (ADT) | EXPERIMENTAL | In the main study, participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days). Participants who enrolled in the sub-study will receive apalutamide 240 mg once daily along with relugolix (a type of ADT) 120 mg once daily following a loading dose of 360 mg relugolix orally. Sub-study participants will be receiving relugolix up to Day 28 after which they will be transitioned into the main study from Cycle 2 Day 1 and will continue to receive conventional or oral ADT. |
| Apalutamide plus GnRH Agonist | EXPERIMENTAL | Participants will receive apalutamide 240 milligram (mg) in combination with a gonadotropin-releasing hormone (GnRH) agonist until disease progression, unacceptable toxicity, death, or the end of the study and each treatment cycle will be of 28 days. Participants who are benefitting from this study will enter long term extension phase. |
| Arm 1 (radiation therapy, placebo) | ACTIVE_COMPARATOR | Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Arm 2 (radiation therapy, apalutamide) | EXPERIMENTAL | Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| active surveillance | NO_INTERVENTION | Active surveillance without androgen deprivation |
| active surveillance with Apalutamide | EXPERIMENTAL | Active surveillance during and after 6 months treatment with Apalutamide |
| Phase I: Dose Escalation | EXPERIMENTAL | Phase I will identify a biologically active and tolerable (safe) dose range of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC). |
| Phase II: Dose Expansion | EXPERIMENTAL | Phase I will investigate the anti-tumour activity of tolerable doses of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC). Patients will be treated at dose levels deemed to be tolerable and biologically active, based on safety and efficacy data from Dose Escalation. |
| Group 1: Participants with Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment will receive single oral dose of apalutamide on Day 1 under fasted condition. |
| Group 2: Participants with Normal Hepatic Function | EXPERIMENTAL | Participants with normal hepatic function will receive single oral dose of apalutamide on Day 1 under fasted condition. |
| Apalutamide | EXPERIMENTAL | Participants will receive a single oral dose of apalutamide 240 milligram (mg) during pharmacokinetics (PK) Week Day 1 and will be monitored for one week (that is; PK Week) to assess PK and safety of drug. Subsequently, participants will further receive daily treatment of apalutamide from Cycle 1 Day 1 onwards until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. Each treatment cycle consists of 28 days. After final analysis (FA), participants who are receiving apalutamide in the open-label treatment phase may continue receiving single oral dose apalutamide 240 mg once daily in a long-term extension (LTE) phase if they continue to derive benefit from treatment (based on investigator assessment). |
| Cohort 1 | EXPERIMENTAL | Participants will receive 8 capsules of JNJ-56021927, 240 milligram (mg) as single oral dose on Day 1. After participants will receive daily JNJ-56021927, 240 mg on Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first. |
| Name | Type | Description |
|---|---|---|
| Apalutamide | DRUG | Apalutamide will be administered orally from Day 1 of Cycle 1 till 6 months in initial treatment phase and then in main treatment phase from Day 1 of Cycle 7 up to at least 18 months. |
| Androgen-deprivation Therapy (ADT) | DRUG | The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information. |
| Bicalutamide | DRUG | Given bicalutamide |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Scan | PROCEDURE | Undergo bone scan |
| Buserelin | DRUG | Given buserelin |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Degarelix | DRUG | Given degarelix |
| Flutamide | DRUG | Given flutamide |
| Goserelin | DRUG | Given goserelin |
| Histrelin | DRUG | Given histrelin |
| Leuprolide | DRUG | Given leuprolide |
| Magnetic Resonance Elastography | PROCEDURE | Undergo MRI |
| Positron Emission Tomography | PROCEDURE | Undergo PET scan |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
| Radiation Therapy | RADIATION | Undergo radiation therapy |
| Relugolix | DRUG | Given relugolix |
| Triptorelin | DRUG | Given triptorelin |
| Radiotherapy | RADIATION | Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization. |
| LHRHa | DRUG | Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization. |
| 3-Dimensional Conformal Radiation Therapy | RADIATION | Undergo 3D CRT |
| External Beam Radiation Therapy | RADIATION | Undergo EBRT |
| Fluciclovine F18 | OTHER | Given IV |
| Goserelin Acetate | DRUG | Given SC |
| Intensity-Modulated Proton Therapy | PROCEDURE | Undergo IMPT |
| Intensity-Modulated Radiation Therapy | RADIATION | Undergo IMRT |
| Leuprolide Acetate | DRUG | Given IM |
| Magnetic Resonance Imaging | PROCEDURE | Undergo PET/MR |
| Stereotactic Body Radiation Therapy | RADIATION | Undergo SBRT |
| Volume Modulated Arc Therapy | RADIATION | Undergo VMAT |
| Hormone Therapy | DRUG | Receive hormone therapy |
| Androgen Deprivation Therapy (ADT) | DRUG | Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]). |
| Placebo | DRUG | Participants will receive matching placebo oral tablets daily. |
| Gallium Ga 68 Gozetotide | OTHER | Undergo PSMA-PET/CT |
| Guided Stereotactic Body Radiation Therapy | RADIATION | Undergo guided SBRT |
| Multiparametric Magnetic Resonance Imaging | PROCEDURE | Undergo multiparametric MRI |
| Apalutamide 60mg Tab | DRUG | 4 tablets by mouth once a day for 24 weeks |
| Abiraterone Acetate 250mg | DRUG | 4 tablets by mouth on an empty stomach once a day for 16 weeks |
| Prednisone 5mg Tab | DRUG | 1 tablet by mouth once daily while taking abiraterone acetate |
| Docetaxel | DRUG | Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks) |
| Niraparib 100mg Oral Capsule | DRUG | 3 capsules by mouth once daily for 16 weeks |
| Atezolizumab | DRUG | 1200mg infusion every 3 weeks for 6 cycles |
| Tazemetostat Pill | DRUG | 200 mg 4 tablets by mouth twice daily with or without food for 16 weeks |
| Capivasertib | DRUG | 200 mg 2 tablets by mouth twice a day with or without food on an intermittent dosing schedule (days 1-4, then 3 days off) each week for 16 weeks |
| ADT | DRUG | Participants will receive ADT intramuscular or subcutaneously during the main study. |
| GnRH Agonist | DRUG | A stable regimen of goserelin 3.6 mg will be administered as a GnRH agonist. |
| Placebo Administration | OTHER | Given PO |
| SX-682 | DRUG | SX-682 is supplied as 100mg film coated tablets. |
| JNJ-56021927 | DRUG | Participants will receive 8 capsules of JNJ-56021927, 240 milligram (mg) as single oral dose on Day 1. After participants will receive daily JNJ-56021927, 240 mg on Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first. |
Inclusion Criteria: * Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate * For participants not undergoing Gender-affirming care: Metastatic prostate cancer disease documented by conventional imaging (example, computed tomog...
JNJ-56021927 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer, a form of prostate cancer that progresses despite androgen deprivation therapy. It is currently in clinical development and has not been approved by regulatory authorities.
JNJ-56021927 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational oncology therapy in early-stage clinical development.
JNJ-56021927 is in Phase 1 clinical development. A Phase 1 safety study of the drug has been completed, and it remains an investigational agent that has not received regulatory approval. Further clinical trials would be needed to establish its safety and efficacy.
JNJ-56021927 has one completed clinical trial, NCT02162836, a Phase 1 safety study in participants with metastatic castration-resistant prostate cancer. The study enrolled 6 male participants aged 20 years and older in Japan and was not randomized or blinded.
JNJ-56021927 is an investigational drug being developed by Johnson & Johnson for metastatic castration-resistant prostate cancer. The available information does not indicate that JNJ-56021927 is the same as apalutamide, which is a different marketed product.