Floatz Rating
B61/100
Confidence
Indicative
Sponsor
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
62High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07333066CT.gov Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial. | — | Recruiting | — | — | — |
NCT06931340CT.gov Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial | — | Recruiting | — | — | — |
NCT07406282CT.gov A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics | — | Recruiting | — | — | — |
NCT07086651CT.gov A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) | — | Completed | — | — | — |
NCT06652607CT.gov PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer | — | Recruiting | — | — | — |
NCT06758882CT.gov Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET | — | Recruiting | — | — | — |
NCT06274047CT.gov PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. | — | Recruiting | — | — | — |
NCT06505278CT.gov The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy | — | Not Yet Recruiting | — | — | — |
NCT06378866CT.gov Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial | — | Recruiting | — | — | — |
NCT06430411CT.gov Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study | — | Not Yet Recruiting | — | — | — |
Show 62 more trialsShow fewer
NCT05960578CT.gov Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study | — | Active Not Recruiting | — | — | — |
NCT06067269CT.gov Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial | — | Recruiting | — | — | — |
NCT06204302CT.gov An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States | — | Completed | — | — | — |
NCT05884398CT.gov A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC | — | Active Not Recruiting | — | — | — |
NCT05901649CT.gov A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide | — | Active Not Recruiting | — | — | — |
NCT05717582CT.gov Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment | — | Not Yet Recruiting | — | — | — |
NCT05818683CT.gov A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer | — | Recruiting | — | — | — |
NCT05191680CT.gov TherApeutics in Early ProState Cancer (TAPS02) | — | Recruiting | — | — | — |
NCT05778097CT.gov Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study) | — | Not Yet Recruiting | — | — | — |
NCT05717660CT.gov APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer | — | Unknown | — | — | — |
NCT05751941CT.gov Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer | — | Recruiting | — | — | — |
NCT05683964CT.gov Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression | — | Active Not Recruiting | — | — | — |
NCT05422911CT.gov Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. | — | Recruiting | — | — | — |
NCT05212857CT.gov Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer | — | Unknown | — | — | — |
NCT04926181CT.gov Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer | — | Terminated | — | — | — |
NCT05202301CT.gov A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely | — | Completed | — | — | — |
NCT05740488CT.gov Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases | — | Unknown | — | — | — |
NCT04812366CT.gov Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer | — | Recruiting | — | — | — |
NCT04947254CT.gov Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer | — | Recruiting | — | — | — |
NCT04530552CT.gov Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland | — | Active Not Recruiting | — | — | — |
NCT03902951CT.gov Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT04997252CT.gov An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer | — | Unknown | — | — | — |
NCT04513717CT.gov Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial | — | Active Not Recruiting | — | — | — |
NCT02811809CT.gov Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer | — | Withdrawn | — | — | — |
NCT04585932CT.gov Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study | — | Withdrawn | — | — | — |
NCT04423211CT.gov Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging | — | Recruiting | — | — | — |
NCT07428642CT.gov PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. | — | Completed | — | — | — |
NCT04409288CT.gov Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer | — | Terminated | — | — | — |
NCT04421222CT.gov Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer | — | Terminated | — | — | — |
NCT04267887CT.gov Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT03777982CT.gov Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT | — | Terminated | — | — | — |
NCT04134260CT.gov Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial | — | Recruiting | — | — | — |
NCT03488810CT.gov Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer | — | Withdrawn | — | — | — |
NCT05406999CT.gov Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer | — | Recruiting | — | — | — |
NCT04181203CT.gov Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy | — | Active Not Recruiting | — | — | — |
NCT03821792CT.gov Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT03080116CT.gov Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy | — | Active Not Recruiting | — | — | — |
NCT02789878CT.gov Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer | — | Completed | — | — | — |
NCT03298087CT.gov Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer | — | Completed | — | — | — |
NCT03436654CT.gov Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma | — | Active Not Recruiting | — | — | — |
NCT03365297CT.gov Therapeutics in Active Prostate Cancer Surveillance | — | Completed | — | — | — |
NCT03311555CT.gov A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR) | — | Completed | — | — | — |
NCT03412396CT.gov Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy | — | Active Not Recruiting | — | — | — |
NCT03360721CT.gov Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer | — | Terminated | — | — | — |
NCT03141671CT.gov Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509) | — | Unknown | — | — | — |
NCT03279250CT.gov Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer | — | Completed | — | — | — |
NCT02867020CT.gov Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels | — | Completed | — | — | — |
NCT03098836CT.gov Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer | — | Completed | — | — | — |
NCT03093272CT.gov A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer | — | Terminated | — | — | — |
NCT03088124CT.gov Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer | — | Completed | — | — | — |
NCT02849990CT.gov A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy | — | Completed | — | — | — |
NCT03009981CT.gov A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer | — | Completed | — | — | — |
NCT06473259CT.gov Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients | — | Recruiting | — | — | — |
NCT02903368CT.gov Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy | — | Completed | — | — | — |
NCT02770391CT.gov Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer | — | Completed | — | — | — |
NCT02772588CT.gov AASUR in High Risk Prostate Cancer | — | Completed | — | — | — |
NCT02489318CT.gov A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC | — | Active Not Recruiting | — | — | — |
NCT02366494CT.gov Micro RNAs to Predict Response to Androgen Deprivation Therapy | — | Completed | — | — | — |
NCT02106507CT.gov ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate | — | Completed | — | — | — |
NCT01790126CT.gov The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer | — | Completed | — | — | — |
NCT01792687CT.gov Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate | — | Completed | — | — | — |
NCT01171898CT.gov Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Prostate Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Apalutamide (this asset) | Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD | P3 | B · 61 |
| Avodart | Bay State Clinical Trials, Inc. | P4 | BBB |
| Desflurane | Peter MacCallum Cancer Centre, Australia | P4 | BBB |
| Propofol | Peter MacCallum Cancer Centre, Australia | P4 | BBB |
| Degarelix | Bayer | P4 | BBB |
| Flotufolastat F 18 | Washington University School of Medicine | P4 | BB |
| AVOLVE | Masonic Cancer Center, University of Minnesota | P4 | BB |
| Estramustine | The University of Texas Health Science Center, Houston | P3 | BB |
| Pasireotide | RECORDATI GROUP | P4 | BB |
+42 more in the Prostate Cancer cohort
Other indications for Apalutamide
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Prostate Neoplasm | — | P4 | BB · 67 |
| Metastatic Prostate Carcinoma | — | P4 | BB · 67 |
| Prostate Carcinoma | — | P3 | BB · 64 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Apalutamide in Prostate Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/apalutamide-prostate-cancer
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