Prostate cancer
Prostate cancer is the home of theranostics: PSMA PET finds it, PSMA radioligands treat it. Hormonal therapy remains the foundation, with PARP and AKT inhibitors added by genotype.
Overview
Prostate cancer is the most common cancer in men in most high-income countries and a spectrum: most PSA-detected disease is indolent and safely watched (ProtecT: ~3% prostate-cancer mortality at 15 years whatever the strategy), while de novo metastatic disease, treated with hormonal doublets and triplets and since 2026 with radioligand therapy added, still has a median survival of about five years, which makes it the second most common cause of cancer death in men. Diagnosis now runs PSA → multiparametric MRI (PRECISION) → targeted biopsy → Grade Group, with germline and somatic HRR testing for advanced disease and PSMA PET for staging (proPSMA) and recurrence. Digital-pathology AI (ArteraAI Prostate, 2025) and gene-expression classifiers (Decipher) refine who needs treatment and who benefits from adding hormone therapy.
Treatment is built on androgen deprivation, the first targeted cancer therapy (Huggins, 1941). Metastatic hormone-sensitive disease is treated with doublets (ADT + abiraterone, enzalutamide, apalutamide or darolutamide) or triplets adding docetaxel (ARASENS, PEACE-1), and since 31 July 2026 with 177Lu-PSMA-617 added to ADT + ARPI (PSMAddition, rPFS HR 0.72). PTEN-deficient disease gained capivasertib + abiraterone in 2026. In castration-resistant disease the sequence includes ARPI switch, PARP inhibitors for HRR-mutant tumours (PROfound, PROpel, TALAPRO-2 with OS benefit), docetaxel and cabazitaxel, radium-223 for bone-only disease, and 177Lu-PSMA-617 before or after chemotherapy (VISION, PSMAfore). Enzalutamide is approved even for high-risk PSA-only recurrence (EMBARK).
Prostate cancer is the proving ground for theranostics: PSMA PET selects and PSMA radioligands treat. Competing 177Lu-PSMA-I&T products (SPLASH, ECLIPSE) have improved progression but not yet survival; alpha-emitting 225Ac-PSMA agents are in phase 3 (AlphaBreak, AcTION) and produce responses after lutetium failure. T-cell engagers against STEAP1 (xaluritamig, XALute) and KLK2 (pasritamig) are the first immunotherapies with real activity in a disease that ignores checkpoint inhibitors; EZH2 inhibition (mevrometostat, MEVPRO) aims to re-sensitise to hormonal therapy. The unsolved problems are neuroendocrine transformation, AR-V7-driven resistance (the N-terminal-domain inhibitor masofaniten failed), Ac-225 supply, and the over- versus under-diagnosis tension in screening.
State of the art
- Theranostic pairing of PSMA PET and Pluvicto.
- Genotype-directed doublets.
- AI pathology guiding ADT duration.
- Radioligand therapy across the metastatic continuum: 177Lu-PSMA-617 approved post-taxane (2022), pre-taxane (2025), and at first metastatic diagnosis with ARPI (31 July 2026).
- Triplet therapy (ADT + ARPI + docetaxel) for high-volume de novo disease, with OS HR ~0.7 (ARASENS, PEACE-1).
- Genotype-directed doublets: PARP inhibitor + ARPI for HRR-mutant (OS benefit in TALAPRO-2) and capivasertib + abiraterone for PTEN-deficient disease (2026).
- Diagnostic pathway rebuilt around MRI-first biopsy and PSMA PET staging; active surveillance is default for low-risk disease.
- AI pathology (ArteraAI Prostate) is FDA-authorised to predict who benefits from adding hormone therapy to radiation.
- First immunotherapies with real activity: STEAP1 and KLK2 T-cell engagers in phase 3, after checkpoint inhibitors failed in unselected disease.
Anatomy and lymph node drainage
- Peripheral zone (most indications)
- Transition zone (BPH)
- Ducts (ductal, intraductal, neuroendocrine)
- Seminal vesicle (T3b)
- Nodes: obturator
- Nodes: internal iliac
- Nodes: external iliac
- Nodes: presacral
About three quarters of indications arise in the peripheral zone at the back of the gland, the part a finger or a biopsy needle reaches; drainage is to the obturator and iliac nodes.
- Peripheral zone (most indications)Localised: low / favourable-intermediate / unfavourable-intermediate / high risk (NCCN) · Non-metastatic castration-resistant (nmCRPC) · Metastatic hormone-sensitive (mHSPC; FDA 2026 term 'androgen pathway modulation-naive or -sensitive'), de novo vs recurrent, high vs low volume (CHAARTED) · Metastatic castration-resistant (mCRPC) · HRR-mutant (~20-25% of mCRPC; BRCA2 most actionable) · Treatment-emergent neuroendocrine prostate cancer (~15-20% of late mCRPC)
- Transition zone (BPH)
- Ducts (ductal, intraductal, neuroendocrine)Treatment-emergent neuroendocrine prostate cancer (~15-20% of late mCRPC) · Ductal and intraductal / cribriform variants (aggressive)
- Seminal vesicle (T3b)
- obturator
- internal iliac
- external iliac
- presacral
Same organ: Localised prostate cancer, high and very high risk, Biochemical recurrence of prostate cancer, Metastatic hormone-sensitive prostate cancer, Non-metastatic castration-resistant prostate cancer, Metastatic castration-resistant prostate cancer, Neuroendocrine and small-cell prostate cancer
Preclinical models
7 cell lines, 3 mouse models and 6 repositories are listed for this cancer.
~1.5 million new cases per year worldwide; lifetime risk ~1 in 8 men in high-income countries; median age at diagnosis 67; most PSA-detected disease is indolent and safely watched.
Show survival figures (1)
Averages across everyone diagnosed, often years ago. Your stage, subtype, age, fitness and the treatment you receive matter more than the average, and the numbers are improving quickly.
- ~400,000 deaths per year worldwide, mostly from disease that was already metastatic at diagnosis.
- Fluciclovine F-18Approved
- PSMA PETStandard of care
Nothing recorded yet.
Nothing recorded yet.
Also on Nuclide: Roadmaps.
Advanced diseaseShow Hide where advanced disease can reach, and what treats itThe sites decide which scans are done at staging and follow-up, and every site listed has a treatment approach.
Most people reading this do not have advanced disease. The map describes what can happen over the whole course of the illness, across autopsy and registry series; today's staging scans find spread earlier, and each site has treatments, from focused radiotherapy for a few spots to drugs that reach the brain.
What helpsAndrogen deprivation with an AR pathway inhibitor, docetaxel, PARP inhibitors for HRR mutations, radium-223 for bone-predominant disease and 177Lu-PSMA-617 selected by PSMA PET; bone-protecting drugs throughout.
- Abiraterone acetateApproved
- DocetaxelApproved
- Lutetium-177 vipivotide tetraxetanApproved
- PSMA PETStandard of care
- Radioligand therapy (beta emitters)Approved
- Radium-223 dichlorideApproved
- [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate CancerActive
- 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid TumorsRecruiting
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)Recruiting
- A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate CancerRecruiting
- A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard TherapyActive
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate CancerRecruiting
Background: Oligometastatic disease. Also on Nuclide: Indications.
- Bone (spine, pelvis, ribs)most common
65-75% of patients with advanced disease develop bone metastases. Typically bone-forming (sclerotic) lesions; PSMA PET finds them early.
- Distant lymph nodescommon
- Liverless common
Liver spread marks aggressive, often neuroendocrine-like disease.
- Lungsless common
- Brainrare
Active surveillance, prostatectomy, or radiation ± ADT (duration guided by risk/ArteraAI).
ADT + ARPI ± docetaxel; PSMA PET staging; capivasertib if PTEN-deficient.
ARPI switch, PARP inhibitor combinations (HRR+), 177Lu-PSMA-617, docetaxel/cabazitaxel, radium-223.
Shared-decision PSA testing from 50 (45 if Black or family history/BRCA), risk-adapted intervals; MRI before biopsy; avoid biopsy if MRI negative and PSA density low.
Active surveillance (PSA, MRI, repeat biopsy) for Grade Group 1 and many favourable GG2; genomic classifier or ArteraAI to refine.
Radical prostatectomy (robotic) or radiotherapy (hypofractionated IMRT, SBRT, or brachytherapy boost) with 4-6 months (intermediate) to 18-36 months (high risk) of ADT; abiraterone added for very high risk (STAMPEDE); ArteraAI predicts ADT benefit.
PSMA PET to localise; salvage radiotherapy ± ADT after prostatectomy; metastasis-directed SBRT for oligorecurrence (investigational for survival); enzalutamide ± ADT for high-risk BCR (EMBARK).
ADT (GnRH agonist/antagonist, e.g., relugolix) + ARPI (abiraterone, enzalutamide, apalutamide, or darolutamide); add docetaxel for high-volume de novo disease (ARASENS, PEACE-1); add 177Lu-PSMA-617 if PSMA-positive (PSMAddition, approved 31 Jul 2026); capivasertib + abiraterone if PTEN-deficient (2026); prostate RT for low-volume disease.
Apalutamide, enzalutamide, or darolutamide (SPARTAN, PROSPER, ARAMIS); PSMA PET usually reclassifies as metastatic.
ARPI (if not used earlier); PARP inhibitor + ARPI for BRCA/HRR-mutant (olaparib-abiraterone, talazoparib-enzalutamide, niraparib-abiraterone); docetaxel; 177Lu-PSMA-617 after one ARPI before chemotherapy (PSMAfore); pembrolizumab if MSI-high.
177Lu-PSMA-617 post-taxane (VISION); cabazitaxel (CARD); radium-223 for bone-only symptomatic disease (with bone protection); 225Ac-PSMA, xaluritamig, pasritamig, mevrometostat in trials; platinum-etoposide for neuroendocrine transformation; tarlatamab/I-DXd trials for DLL3/B7-H3.
Subtypes & biomarkers
top- Localised : low / favourable-intermediate / unfavourable-intermediate / high risk (NCCN)
- Non-metastatic castration-resistant (nmCRPC)
- Metastatic hormone-sensitive (mHSPC; FDA 2026 term 'androgen pathway modulation-naive or -sensitive'), de novo vs recurrent, high vs low volume (CHAARTED)
- Metastatic castration-resistant (mCRPC)
- HRR-mutant (~20-25% of mCRPC; BRCA2 most actionable)
- PTEN-deficient (~25%)
- PSMA-low / heterogeneous (~10%)
- Treatment-emergent neuroendocrine prostate cancer (~15-20% of late mCRPC)
- Ductal and intraductal / cribriform variants (aggressive)
- PSA
- Gleason / Grade Group
- PSMA PET
- HRR genes (BRCA2, ATM, etc.)
- PTEN
- MSI
- AR-V7 (research)
- Decipher / ArteraAI
- PSA, PSA density, PSA doubling time
- Grade Group (Gleason) and cribriform/intraductal pattern
- mpMRI PI-RADS score
- PSMA PET (SUVmax, total tumour volume) for staging and radioligand eligibility
- Germline and somatic HRR genes (BRCA2, BRCA1, ATM, PALB2, CDK12)
- PTEN loss (IHC or NGS) for capivasertib
- MSI/dMMR (~3%, pembrolizumab)
- Decipher genomic classifier; ArteraAI digital pathology
- AR-V7 (CTC) in research/limited use
- Testosterone level (castration confirmation)
- Neuroendocrine markers (chromogranin, synaptophysin, RB1/TP53 loss) on progression
How often this target appears
| Target / alteration | Prevalence | Measure | Source |
|---|---|---|---|
| GRPR (gastrin-releasing peptide receptor) Markwalder and Reubi 1999 (Cancer Res); receptor density was high in carcinoma and PIN and low or absent in normal and hyperplastic prostate | 100% | Receptor autoradiography, GRPR in 30 of 30 invasive prostate carcinomas | PMC |
| PSMA ~10% PSMA-negative or low | >90% | PSMA PET positivity, metastatic disease | PMC |
| B7-H3 Castration-resistant disease | 80-90% | IHC, any expression | Wikipedia |
| DLL3 Rare in adenocarcinoma | 70-80% | Neuroendocrine prostate cancer only | Wikipedia |
| PARP BRCA2 ~8-10% | 20-25% | HRR gene alteration (mCRPC) | cBioPortal (TCGA) |
How common each drug target or alteration is in this cancer. Population-level and approximate; see the target page for detail.
- 1941Huggins: castration controls prostate cancer
- 1941Huggins shows castration controls metastatic prostate cancer
Nobel Prize 1966; the first hormonal therapy of any cancer.
- 1966Gleason grading system published
- 1986PSA test approved for monitoring; screening spreads in the 1990s
- 2004Docetaxel: first chemotherapy to extend survival (TAX 327)
- 2011Abiraterone approved
- 2011Abiraterone approved; enzalutamide follows in 2012
Proof that castration-resistant disease is still AR-driven.
- 2013Radium-223: first alpha emitter approved
- 2013Radium-223: first alpha emitter approved (ALSYMPCA)
- 2015CHAARTED and STAMPEDE: docetaxel at first metastatic diagnosis
- 2016ProtecT validates active surveillance
- 2017LATITUDE and STAMPEDE: abiraterone in mHSPC
- 2018PRECISION: MRI before biopsy
- 2020PSMA PET approved; olaparib in HRR-mutant mCRPC
- 2020PSMA PET approved; PROfound approves olaparib for HRR-mutant mCRPC
- 2021VISION: 177Lu-PSMA-617 improves survival; TheraP beats cabazitaxel on response
- 2022Pluvicto approved
- 2022Pluvicto approved; ARASENS establishes triplet therapy
- 2023PARP + ARPI combinations approved (TALAPRO-2, PROpel, MAGNITUDE); EMBARK for biochemical recurrence
- 2024SPLASH: second PSMA radioligand improves rPFS but not OS
- 2025ArteraAI Prostate: first predictive AI pathology test
- 2025Pluvicto pre-chemotherapy (PSMAfore); ArteraAI Prostate FDA-authorised; PSMAddition positive; ECLIPSE positive; masofaniten discontinued
- 2026Pluvicto approved in metastatic hormone-sensitive disease (31 July); capivasertib + abiraterone approved for PTEN-deficient disease
Dated changes read from the records linked to this indication: approvals, regulatory steps, reported trials, guideline versions and milestones. Newest first; no date is inferred.
All 60 changes by month →- 2026-09-06This recordProstate cancerFacts on this page last checked
When this page itself was last checked or edited.
- 2026-07-31RegulatoryLutetium-177 vipivotide tetraxetanLutetium-177 vipivotide tetraxetan: approval (US)
PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition)
- 2026-06-08RegulatoryGallium-68 gozetotide (PSMA-11)Gallium-68 gozetotide (PSMA-11): approval (US)
Gallium Ga 68 gozetotide from RadioMedix approved under an abbreviated new drug application, ANDA 216410 (original approval)
- 2026-04-30RegulatoryFlorastamin F-18Florastamin F-18: approval (South Korea)
MFDS marketing approval as Korea's 43rd domestically developed new drug
- 2026-03-09RegulatoryPiflufolastat F-18 / Pylarify TruVuPiflufolastat F-18 / Pylarify TruVu: approval (US)
Pylarify TruVu formulation
- 2026ApprovalFlorastamin F-18Florastamin F-18 approved in South Korea
PET imaging of PSMA-positive lesions in men with prostate cancer whose existing imaging suggests recurrence or metastasis
What is in development for Prostate cancer, drawn from the whole corpus: 75 items. Drugs are grouped by the most advanced trial phase they have reached anywhere; approved treatments sit under standard of care. Technologies are the methods being tested for this cancer, trials are the studies recorded here, and ideas are proposals not yet in a trial.
Drugs in phase 3 · 6
Drugs in phase 2 · 1
Drugs in emerging · 1
Technologies being tested · 4
Trials under way · 42
- AlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617) · phase 2 · AstraZeneca (Fusion); Novartis
- [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer · phase 3 · FutureChem
- 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors · phase 1/2 · Radiopharm Theranostics, Ltd
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) · phase 1/2 · Clarity Pharmaceuticals Ltd
- A Clinical Trial Evaluating the Safety of TD001 In Patients With PSMA-Expressing Metastatic Prostate Cancer · phase 1/2 · T.O.A.D. Oncology SA
- A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy · phase 1/2 · Cellbion Co., Ltd.
- A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC · phase 1/2 · Norroy Bioscience Co., LTD
- A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA · phase 1/2 · Novartis Pharmaceuticals
- A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC · phase 2 · Novartis Pharmaceuticals
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer · phase 3 · Jiangsu HengRui Medicine
- A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS · phase 1/2 · Antelope Surgical Solutions, Inc
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer · phase 2 · Novartis Pharmaceuticals
- A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer · phase 3 · Janssen Pharmaceutica N.V., Belgium
- A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer · phase 1/2 · GlaxoSmithKline
- A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) · phase 2 · Novartis Pharmaceuticals
- A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) · phase 3 · Janssen Research & Development
- A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC · phase 1/2 · Radiopharm Theranostics, Ltd
- A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC · phase 1/2 · C Ray Therapeutics
- A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metasta · phase 1/2 · Regeneron Pharmaceuticals
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. · phase 3 · Novartis Pharmaceuticals
- An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC · phase 2 · Novartis Pharmaceuticals
- Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection · phase 1/2 · Blue Earth Therapeutics Ltd
- AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) · phase 3 · AstraZeneca
- Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer · phase 1/2 · Five Eleven Pharma, Inc.
- Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer · phase 3 · Curium US LLC
- Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer · phase 3 · ABX advanced biochemical compounds GmbH
- Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis · phase 3 · FutureChem
- FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) · phase 2 · Fusion Pharmaceuticals Inc.
- Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer. · phase 3 · Norroy Bioscience Co., LTD
- ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC · phase 1/2 · OncoC4, Inc.
- Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy · phase 2/3 · Novartis Pharmaceuticals
- Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer · phase 1/2 · Bivision Pharmaceuticals, Inc.
- Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer · phase 1/2 · AstraZeneca
- PSMA PET Combined With MRI for the Detection of PCa · phase 3 · Telix Pharmaceuticals (Innovations) Pty Limited
- PSMA-PET to Guide Prostatectomy · phase 2/3 · Five Eleven Pharma, Inc.
- Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer · phase 2 · Curasight
- Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC · phase 3 · Novartis Pharmaceuticals
- Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC) · phase 2 · Convergent Therapeutics
- Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function · phase 2 · Novartis Pharmaceuticals
- Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST). · phase 2 · Fusion Pharmaceuticals Inc.
- The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) · phase 3 · Telix Pharmaceuticals (Innovations) Pty Limited
- This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer. · phase 3 · Norroy Bioscience Co., LTD
Trials reported · 14
- ECLIPSE · phase 3 · 2025 · positive
- ALSYMPCA · phase 3 · 2013 · positive
- CHAARTED (E3805) · phase 3 · 2015 · positive
- EMBARK · phase 3 · 2023 · positive
- POP-RT · phase 3 · 2021 · positive
- proPSMA · phase 3 · 2020 · positive
- PROSPER · phase 3 · 2018 · positive
- PSMAddition · phase 3 · 2025 · positive
- PSMAfore · phase 3 · 2023 · positive
- SPLASH · phase 3 · 2024 · mixed
- STAMPEDE · platform trial · 2016 · positive
- Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer · phase 3 · completed
- TheraP (ANZUP 1603) · phase 2 · 2021 · positive
- VISION · phase 3 · 2021 · positive
Targets under investigation · 1
Combinations being explored · 2
Ideas not yet in a trial · 4
Open problems and what is being done
Overdiagnosis vs. underdiagnosis in screening.
What is being done about thisFinding cancer earlierAvailable now- Fluciclovine F-18Approved
- PSMA PETStandard of care
In trialsNothing recorded yet.
Ideas and roadmapsNothing recorded yet.
Also on Nuclide: Roadmaps.
Neuroendocrine transformation.
Ac-225 supply.
What is being done about thisCost and accessAvailable now- Radiopharmaceutical GMP and releasing a drug that decaysStandard of care
In trialsIdeas and roadmapsAlso on Nuclide: Approvals and coverage by region.
Screening trade-off: PSA reduces mortality by ~20% but overdiagnoses; MRI-first and risk-adapted intervals are only partly adopted.
What is being done about thisFinding cancer earlierAvailable now- Fluciclovine F-18Approved
- PSMA PETStandard of care
In trialsNothing recorded yet.
Ideas and roadmapsNothing recorded yet.
Also on Nuclide: Roadmaps.
Neuroendocrine / lineage-plastic transformation in ~15-20% of late mCRPC has no targeted therapy; DLL3 and B7-H3 agents are being borrowed from SCLC.
AR-V7 and N-terminal-domain resistance: masofaniten failed; AR degraders remain preclinical/early.
What is being done about thisResistance to treatmentAvailable now- EnzalutamideApproved
In trials- 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid TumorsRecruiting
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)Recruiting
- A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard TherapyActive
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate CancerRecruiting
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate CancerActive
- A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)Active
Ideas and roadmapsNothing recorded yet.
Also on Nuclide: Open problems.
Radioligand sequencing and resistance: 10% PSMA-negative disease, heterogeneity, and no proven therapy after 177Lu failure outside trials; Ac-225 supply is the constraint.
What is being done about thisResistance to treatmentAvailable now- EnzalutamideApproved
In trials- 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid TumorsRecruiting
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)Recruiting
- A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard TherapyActive
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate CancerRecruiting
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate CancerActive
- A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)Active
Ideas and roadmapsNothing recorded yet.
Also on Nuclide: Open problems.
Overall survival has been hard to show for PSMA radioligands beyond VISION (SPLASH, PSMAfore, TheraP confounded by crossover).
Immunotherapy: checkpoint inhibitors fail in unselected disease; engagers bring cytokine release and need outpatient models.
What is being done about thisSide effects and quality of lifeAlso on Nuclide: Dosimetry.
Equity: Black men have ~70% higher incidence and double the mortality yet are under-enrolled in trials; earlier, risk-adapted screening is the lever.
What is being done about thisFinding cancer earlierAvailable now- Fluciclovine F-18Approved
- PSMA PETStandard of care
In trialsNothing recorded yet.
Ideas and roadmapsNothing recorded yet.
Also on Nuclide: Roadmaps.
Bone health, cardiovascular risk, and cognitive effects of long-term ADT in men living a decade or more.
Trials
topTrials recruiting now
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials
Direct links plus the targets, companies, and technologies of this cancer's products.
isotopes
6fronts
1technologies
17targets
8drugs
28companies
25institutions
17pathways
2terms
9trials
56pairings
2roadmaps
2ideas
4collections
2people
18bottlenecks
1key papers
2journals
1This guideline tells doctors and insurers exactly which clinical situations justify a PSMA PET scan for prostate cancer - mainly staging higher-risk disease, investigating a PSA rise after treatment, and checking that a patient's cancer will respond to PSMA radioligand therapy - and which situations do not.
Men with metastatic castration-resistant prostate cancer that has progressed after hormonal therapy and chemotherapy, and whose tumours show PSMA on a PET scan, can now receive lutetium-PSMA, which extends life, controls pain and is usually better tolerated than further chemotherapy. It has established a new treatment class in which a scan decides who gets the matching radioactive drug, and it is now being tested earlier in the disease (PSMAfore, PSMAddition).
Latest papers
topQuery for this indication: (TITLE:"Prostate cancer" OR ABSTRACT:"Prostate cancer") AND (treatment OR therapy OR trial OR survival OR diagnosis). Results are unfiltered search hits about Prostate cancer, not a curated reading list.
Similar pages
not linked directly; found by shared links- IndicationRenal cell carcinoma
Shares UroToday, A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metasta, Oligometastatic disease, Pfizer (incl. Seagen) and the tag gu.
- IsotopeGallium-68
Shares uPAR (urokinase plasminogen activator receptor), Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer., PSMA PET Combined With MRI for the Detection of PCa, This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer..
- IsotopeFluorine-18
Shares A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC, [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer, Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis, Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection.
- IndicationNeuroendocrine tumours
Shares Paola Anna Erba, The Royal Marsden, POINT Biopharma, Uppsala University Hospital / Uppsala University.
- TechnologyPET (positron emission tomography)
Shares PSMA-PET to Guide Prostatectomy, Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer., Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer, This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer..
- TechnologyPET/CT
Shares Chinese PLA General Hospital, Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer., This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer., Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer.
- AgentLutetium-177 dotatate
Shares Uppsala University Hospital / Uppsala University, West German Cancer Center (WTZ), University Hospital Essen, Erasmus MC Cancer Institute, Inselspital, Bern University Hospital / University Cancer Center Inselspital.
- RoadmapAlpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline
Shares AlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617), ALSYMPCA, Alpha-emitting PSMA therapy at first metastatic diagnosis, FPI-2265.