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Clinical Evidence Library

Curated landmark trials and scientific evidence for prostate cancer radioligand therapy, ARPI, chemotherapy, and dosimetry.

> 86 SOURCES LOADED // BAYESIAN PRIORS INTEGRATED

86references
SECTOR_RAD

Radioligand Therapy

Targeted radionuclide therapy with PSMA-ligands (Lu-177, Ac-225) and bone-seeking agents (Ra-223)

Lu-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer PRIORS

Sartor O, de Bono J, et al. (2021)

N Engl J Med 2021
VISION trial: Phase 3 RCT of Lu-177-PSMA-617 + SoC vs SoC alone in mCRPC post-ARPI and taxane. HR 0.62 for OS (95% CI 0....

Lutetium-177-PSMA versus Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer PRIORS

Hofman MS, Emmett L, et al. (2021)

Lancet 2021
TheraP trial: Lu-177-PSMA superior to cabazitaxel for rPFS (HR 0.63, p<0.0001) with better tolerability. Confirmed Lu-17...

Radium-223 and Survival in Metastatic Castration-Resistant Prostate Cancer PRIORS

Parker C, Nilsson S, et al. (2013)

N Engl J Med 2013
ALSYMPCA trial: Ra-223 dichloride prolonged OS in mCRPC with bone metastases (HR 0.70, p<0.001). First alpha-emitter app...

Actinium-225-PSMA-617 in Chemotherapy-Naive Patients with Advanced Prostate Cancer PRIORS

Kratochwil C, Bruchertseifer F, et al. (2018)

J Nucl Med 2018
First prospective Ac-225-PSMA study: 63% PSA response with manageable toxicity. Alpha-particle therapy shows promise for...

Predictors of hematologic toxicity in patients treated with [177Lu]Lu-PSMA-617: a systematic review and meta-analysis

Karimzadeh A, et al. (2025)

Eur J Nucl Med Mol Imaging 2025
Systematic review and meta-analysis of hematologic toxicity predictors in Lu-PSMA therapy.

Nephrotoxicity after [177Lu]Lu-PSMA-617 therapy: incidence, risk factors, and management

Yordanova A, et al. (2017)

Semin Nucl Med 2017

Xerostomia after [177Lu]Lu-PSMA-617 therapy: incidence, predictors, and management

Satapathy S, et al. (2021)

Eur J Nucl Med Mol Imaging 2021

Impact of treatment cycles on toxicity in patients receiving [177Lu]Lu-PSMA-617 therapy

Has Simsek D, et al. (2022)

Eur J Nucl Med Mol Imaging 2022

Prior radium-223 therapy and hematologic toxicity in [177Lu]Lu-PSMA-617 treatment

Ahmadzadehfar H, et al. (2021)

J Nucl Med 2021

Safety analysis of [177Lu]Lu-PSMA-617 in the VISION trial: updated results

Gafita A, et al. (2024)

Eur J Nucl Med Mol Imaging 2024

Predictors of overall survival in metastatic castration-resistant prostate cancer patients receiving [177Lu]Lu-PSMA-617 radioligand therapy

Ahmadzadehfar H, et al. (2017)

Oncotarget 2017

Treatment outcome, toxicity, and predictive factors for radioligand therapy with 177Lu-PSMA-I&T in metastatic castration-resistant prostate cancer

Heck MM, et al. (2019)

Eur Urol 2019

Lu-PSMA-RLT of metastatic castration-resistant prostate cancer: limitations and improvements.

Cao J, Chen Y, et al. (2021)

Annals of nuclear medicine 2021
The prevalence of metastatic castration-resistant prostate cancer (mCRPC) is increasing, and its prognosis is often poor...
SECTOR_AND

Androgen Receptor Pathway Inhibitors (ARPI)

Next-generation androgen pathway inhibitors: abiraterone, enzalutamide, apalutamide, darolutamide

Abiraterone and Increased Survival in Metastatic Prostate Cancer PRIORS

Fizazi K, Tran N, et al. (2017)

N Engl J Med 2017
LATITUDE trial: Abiraterone + ADT in high-volume mHSPC. Landmark study establishing upfront intensification as standard....

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy PRIORS

James ND, de Bono JS, et al. (2017)

N Engl J Med 2017
STAMPEDE abiraterone arm: OS benefit in mHSPC (HR 0.63, p<0.001). Multi-arm multi-stage platform trial confirming upfron...

Enzalutamide in Metastatic Prostate Cancer before Chemotherapy PRIORS

Beer TM, Armstrong AJ, et al. (2014)

N Engl J Med 2014
PREVAIL trial: Enzalutamide in chemotherapy-naive mCRPC. Improved OS (HR 0.71, p<0.001) and rPFS (HR 0.40). Established ...

Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer PRIORS

Chi KN, Agarwal N, et al. (2019)

N Engl J Med 2019
TITAN trial: Apalutamide + ADT in mHSPC. rPFS HR 0.48 (p<0.001), OS HR 0.67. Third ARPI to show mHSPC benefit.
SECTOR_CHE

Chemotherapy (Taxanes)

Docetaxel and cabazitaxel for metastatic prostate cancer

Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer PRIORS

Tannock IF, de Wit R, et al. (2004)

N Engl J Med 2004
TAX 327 trial: First chemotherapy to show OS benefit in mCRPC. Docetaxel 75 mg/m² q3w became standard first-line cytoto...

Cabazitaxel versus Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer PRIORS

de Wit R, de Bono J, et al. (2019)

Lancet 2019
CARD trial: Cabazitaxel superior to ARPI rechallenge post-ARPI progression (HR 0.64, p=0.0011). Established taxane seque...

Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer PRIORS

de Wit R, de Bono J, et al. (2019)

N Engl J Med 2019
CARD trial full report: Cabazitaxel outperforms ARPI switch in post-ARPI mCRPC (imaging PFS HR 0.54, p<0.001).

Prednisone Plus Cabazitaxel or Mitoxantrone for Metastatic Castration-Resistant Prostate Cancer PRIORS

de Bono JS, Oudard S, et al. (2010)

Lancet 2010
TROPIC trial: Cabazitaxel post-docetaxel in mCRPC. HR 0.70 for OS (p<0.0001). First post-docetaxel therapy with survival...
SECTOR_DOS

Dosimetry & Radiobiology

Patient-specific dosimetry, MIRD methodology, alpha/beta-emitter radiobiology

MIRD Pamphlet No. 21: A Generalized Schema for Radiopharmaceutical Dosimetry PRIORS

Bolch WE, Eckerman KF, et al. (2009)

J Nucl Med 2009
Gold standard for radiopharmaceutical dosimetry. Provides schema for cumulative activity (Ã) and S-value methodology. E...

Kidney Dosimetry in Lu-177-PSMA-617 Therapy: Absorbed Doses from MIRD and Voxel-Based Methods PRIORS

Delker A, Ilhan H, et al. (2018)

J Nucl Med 2018
Voxel-based dosimetry shows ~30% inter-patient variability in kidney dose despite fixed activity. Supports need for pati...

Alpha Particle Emitters in Radiation Therapy: Physics and Radiobiology PRIORS

Sgouros G, Bodei L, et al. (2020)

Clin Cancer Res 2020
Alpha particles (Ac-225, Ra-223) deliver high LET radiation over short range (2-10 cell diameters). RBE ~3-7 vs beta. Ox...

Population Pharmacokinetics of Lu-177-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer PRIORS

Violet J, Jackson P, et al. (2019)

Eur J Nucl Med Mol Imaging 2019
Two-compartment PopPK model with FOCE: CL = 0.019 L/h * (WT/70)^0.75 * (1 - 0.008*(CrCl-60)). AUC variability ~30% expla...

EANM Dosimetry Committee Recommendations 2022-2025

Sjogreen Gleisner K, et al. (2022)

Eur J Nucl Med Mol Imaging 2022

Bi-exponential modeling and population pharmacokinetics for Lu-177-PSMA dosimetry

Hardiansyah D, et al. (2025)

EJNMMI Physics 2025

EANM Practical Guidance on Uncertainty Analysis for Molecular Radiotherapy

Gear JI, et al. (2018)

Eur J Nucl Med Mol Imaging 2018

Multi-exponential clearance in Lu-177-PSMA therapy: clinical implications for dosimetry

Kurth J, et al. (2021)

J Nucl Med 2021
GA

Biologically effective dose in fractionated molecular radiotherapy

Gustafsson J, et al. (2013)

Phys Med Biol 2013
SE

OLINDA/EXM: The Second-Generation Personal Computer Software for Internal Dose Assessment

Stabin MG, Sparks RB, Crowe E. (2005)

J Nucl Med 2005
GA

Kidney dosimetry in 177Lu-PSMA therapy: Moving beyond the 23 Gy limit

George Siju C, et al. (2023)

Eur J Nucl Med Mol Imaging 2023
SA

EANM Dosimetry Committee recommendations for dosimetry of 177Lu-labelled PSMA-targeting radiopharmaceuticals

Sjogreen Gleisner K, et al. (2022)

Eur J Nucl Med Mol Imaging 2022

Dosimetry of 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer: Correlations Between Pretherapeutic Imaging and Whole-Body Tumor Dosimetry with Treatment Outcomes PRIORS

Violet J, Jackson P, Ferdinandus J, et al. (2019)

J Nucl Med 2019
Quantitative SPECT/CT dosimetry showing tumor absorbed dose correlation with PSA response and survival. Kidney dose-resp...

MIRD Pamphlet No. 21: A Generalized Schema for Radiopharmaceutical Dosimetry—Standardization of Nomenclature

Bolch WE, Eckerman KF, Sgouros G, Thomas SR (2009)

J Nucl Med 2009
Gold standard MIRD schema for radiopharmaceutical dosimetry. S-value methodology: D = Ã × S. Essential reference for L...

Individualized dosimetry of kidney and bone marrow in patients undergoing 177Lu-DOTA-octreotate treatment PRIORS

Sandström M, Garske-Román U, Granberg D, et al. (2013)

J Nucl Med 2013
EANM dosimetry guidelines: kidney threshold <23 Gy (low risk) to <28 Gy (acceptable risk). Effective half-life methodolo...

Kidney Dosimetry in 177Lu-PSMA-617 Radionuclide Therapy: Absorbed Doses from MIRD and Voxel-Based Methods Versus Measurements PRIORS

Delker A, Ilhan H, Zach C, et al. (2018)

J Nucl Med 2018
Voxel-based vs MIRD dosimetry comparison. 30% inter-patient variability in kidney dose despite fixed activity. Validates...

Population Pharmacokinetics of 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer Patients PRIORS

Violet J, Jackson P, Ferdinandus J, et al. (2019)

Eur J Nucl Med Mol Imaging 2019
Two-compartment PopPK model: CL = 0.019 L/h × (WT/70)^0.75 × (1 - 0.008×(CrCl-60)). AUC variability ~30% explained by...

Prospective Validation of Lu-177-PSMA-617 Dosimetry Imaging Biomarker Analysis

Hofman MS, et al. (2020)

J Nucl Med 2020
SECTOR_BIO

Biomarkers & Imaging

PSMA-PET imaging, PSA kinetics, RECIST, PWG3 criteria

PSMA PET/CT Imaging in Metastatic Castration-Resistant Prostate Cancer PRIORS

Hofman MS, Lawrentschuk N, et al. (2020)

J Clin Oncol 2020
Ga-68-PSMA-11 PET/CT detects 92% of mCRPC lesions with median SUVmax 15.2. Superior to conventional imaging for metastas...

New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (Version 1.1) PRIORS

Eisenhauer EA, Therasse P, et al. (2009)

Eur J Cancer 2009
RECIST 1.1 standard for solid tumor response. Max 5 target lesions (2 per organ), ≤30% reduction = PR, ≥20% increase...

Evaluation of Lymph Nodes with RECIST 1.1

Schwartz LH, Bogaerts J, Ford R, et al. (2009)

Eur J Cancer 2009
RECIST 1.1 lymph node criteria: nodes must be <10 mm short axis for CR; 10-15 mm are non-target; >=15 mm eligible as tar...

A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials

Ruchalski K, et al. (2021)

Radiology: Imaging Cancer 2021
Practical summary of RECIST 1.1 for imaging in clinical trials.

Revised RECIST Guideline (Version 1.1) - RECIST Working Group

Eisenhauer EA, Therasse P, Bogaerts J, et al. (2009)

EORTC 2009
Practical RECIST 1.1 summary document (EORTC PDF).

RECIST 1.1 Summary of Key Facts and Concepts

Merck/MSCRS

Training summary document n.d.
RECIST 1.1 training summary and key concepts.

Prostate Cancer Clinical Trials Working Group 3 (PWG3) Consensus Criteria PRIORS

Scher HI, Morris MJ, et al. (2016)

J Clin Oncol 2016
PWG3 criteria for prostate cancer progression: ≥2 new bone lesions + confirmation scan ≥6 weeks later. Prevents prem...

Bone Scan Use in the Management of Metastatic Castration-Resistant Prostate Cancer

McDonald A, et al. (2020)

Can Urol Assoc J 2020
Discusses bone scan usage and the PCWG3 2+2 confirmation rule for progression.

Prostate Cancer Imaging in Clinical Trials: Applying PCWG3 and RECIST 1.1

Perceptive (2025)

White paper 2025
Industry white paper on applying PCWG3 and RECIST 1.1 in clinical trials.

MET-RADS-P vs PCWG3 Progression Detection in mCRPC (WBMRI vs Bone Scan)

ECR 2025 presentation

ECR Congress 2025
Conference presentation comparing MET-RADS-P and PCWG3 progression detection.

PSA Doubling Time as a Predictor of Clinical Progression in Prostate Cancer PRIORS

D'Amico AV, Moul JW, et al. (2004)

JAMA 2004
PSADT <3 months associated with 12-fold increased risk of death from prostate cancer. Validates PSA kinetics as surrogat...

68Ga-PSMA PET/CT: Joint EANM and SNMMI procedure guideline for prostate cancer imaging

Fendler WP, et al. (2017)

Eur J Nucl Med Mol Imaging 2017

Updated Prognostic Model for Predicting Overall Survival in First-Line Chemotherapy for Patients With Metastatic Castration-Resistant Prostate Cancer

Halabi S, Lin CY, Kelly WK, et al. (2014)

J Clin Oncol 2014
AA

Association of Declining PSA Levels with Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Lu-177-PSMA-617

Armstrong AJ, et al. (2024)

J Clin Oncol 2024

A New Prognostic Score for Predicting Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Radium-223

Frantellizzi V, et al. (2020)

EJNMMI Res 2020

Prognostic Gleason grade grouping: data supporting the new system and a comprehensive review of the literature

Pierorazio PM, Walsh PC, Partin AW, Epstein JI. (2013)

Eur Urol 2013
MA

A novel nomogram for predicting overall survival in metastatic castration-resistant prostate cancer

Modonutti D, et al. (2022)

BJU Int 2022

NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer (Version 1.2024)

National Comprehensive Cancer Network. (2024)

NCCN Guidelines 2024

Ensemble penalized Cox regression for survival prediction in prostate cancer

Laajala TD, et al. (2018)

Sci Rep 2018

Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer

D'Amico AV, Whittington R, Malkowicz SB, et al. (1998)

JAMA 1998
RA

Meta-analysis of PSA Response in Lu-PSMA Therapy

Rios-Sanchez E, Herrmann K, Kim YJ, et al. (2025)

J Nucl Med 2025
Epub ahead of print. PSA50 response 35-46%, PSA90 14-20%.
GA

PSA Nadir Timing and Survival in Lu-PSMA Therapy

Gadot M, Rahbar K, Kind F, et al. (2020)

Eur J Nucl Med Mol Imaging 2020
SA

Bi-exponential PK/PD modeling of PSA kinetics

Siebinga H, et al. (2024)

Clin Pharmacokinet 2024
KE

Early PSA decline predicts overall survival

Kind F, Canada J, Rios-Sanchez E. (2021)

Prostate Cancer Prostatic Dis 2021
CA

Application of PCWG3 criteria in Lu-PSMA trials

Canada J, et al. (2020)

J Clin Oncol 2020

Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multi-centre study PRIORS

Hofman MS, Lawrentschuk N, Francis RJ, et al. (2020)

Lancet 2020
proPSMA trial: PSMA-PET superior to conventional imaging for staging (92% accuracy vs 65%). Pharmacokinetic data for bio...

Prostate-specific membrane antigen PET: clinical utility in prostate cancer, normal patterns, pearls, and pitfalls

Hofman MS, Hicks RJ, Maurer T, Eiber M (2018)

RadioGraphics 2018
PSMA expression patterns: physiologic uptake in salivary glands, kidneys, liver, spleen. Differentiates target (tumor) v...
SECTOR_GEN

Genomics & DDR Mutations

DNA damage repair genes (BRCA1/2, ATM), treatment-emergent neuroendocrine prostate cancer, genomic evolution, and radiation-induced mutations

[177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial PRIORS

Hofman MS, Emmett L, Sandhu S, et al.

Lancet 2021
TheraP trial reported genomic evolution in 15-25% of patients post-Lu-177. DDR mutations associated with enhanced radios...

Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer PRIORS

Sartor O, de Bono J, Chi KN, et al.

N Engl J Med 2021
VISION trial established Lu-177-PSMA as standard of care. Post-hoc genomic analyses showed DDR-mutated tumors had higher...

DNA damage repair (DDR) mutations predict response to 177Lu-PSMA in metastatic castration-resistant prostate cancer (mCRPC) PRIORS

Nauseef JT, Henry GH, et al.

J Clin Oncol 2022
Retrospective analysis: BRCA1/2, ATM, PALB2, CDK12 mutations predict superior PSA response (78% vs 52%, p=0.002) and PFS...

Clinical and Genomic Characterization of Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer: A Multi-institutional Prospective Study PRIORS

Aggarwal R, Huang J, Alumkal JJ, et al.

Cancer Cell 2018
t-NEPC genomics: RB1 loss in 92% of cases, TP53 in 68%, dual loss in 63%. Characterized by chromogranin elevation, PSMA ...

Treatment Outcomes from 177Lu-PSMA-617 Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer Relating to Presence of PSMA PET-Avid Disease and Baseline Tumour Burden PRIORS

Emmett L, Crumbaker M, Ho B, et al.

J Nucl Med 2019
Lu-177 outcomes correlate with PSMA-PET avidity. Genomic evolution observed in 18% at progression. PSMA heterogeneity dr...

Divergent clonal evolution of castration-resistant neuroendocrine prostate cancer PRIORS

Beltran H, Prandi D, Mosquera JM, et al.

Nat Med 2016
t-NEPC arises from clonal divergence (not transdifferentiation) in 48% of cases. Shared truncal mutations (62%) with ade...

Plasma Androgen Receptor and Docetaxel for Metastatic Castration-resistant Prostate Cancer PRIORS

Conteduca V, Wetterskog D, Sharabiani MTA, et al.

Eur Urol 2020
AR-V7 positivity in 19% of mCRPC. Lu-177-PSMA remains effective in AR-V7+ patients (PSA response ~50-60%), unlike ARAT r...

Rb1 and Trp53 cooperate to suppress prostate cancer lineage plasticity, metastasis, and antiandrogen resistance PRIORS

Ku SY, Rosario S, Wang Y, et al.

Science 2017
RB1/TP53 dual loss drives neuroendocrine differentiation and lineage plasticity. Radiation (including Lu-177) can accele...

SOX2 promotes lineage plasticity and antiandrogen resistance in TP53- and RB1-deficient prostate cancer PRIORS

Mu P, Zhang Z, Benelli M, et al.

Science 2017
SOX2 upregulated in 81% of RB1/TP53-deficient tumors. Drives neuroendocrine lineage switch via epigenetic plasticity. Me...
SECTOR_STA

Statistical Models & Methods

Core statistical methodology, survival analysis, and machine learning methods used across modules

GD

Bayesian Data Analysis

Gelman A, Carlin JB, Stern HS, Rubin DB (2013)

Chapman and Hall/CRC 2013
Foundational Bayesian methods textbook. Prior/posterior distributions, MCMC, hierarchical modeling used in trial simulat...

Regression Models and Life-Tables

Cox DR (1972)

Journal of the Royal Statistical Society Series B 1972
Cox proportional hazards model for survival analysis. HR estimation methodology used in OS/PFS predictions.

XGBoost: A Scalable Tree Boosting System

Chen T, Guestrin C. (2016)

Proc. 22nd ACM SIGKDD Int. Conf. on Knowledge Discovery and Data Mining 2016
GA

Bayesian Data Analysis (3rd ed.)

Gelman A, et al. (2013)

Chapman and Hall/CRC 2013
Statistical methodology reference for survival modeling.

The Statistical Analysis of Failure Time Data (2nd ed.)

Kalbfleisch JD, Prentice RL. (2002)

Wiley 2002
Survival analysis reference text.

Modeling Survival Data: Extending the Cox Model

Therneau TM, Grambsch PM. (2000)

Springer 2000
Cox model extensions for survival analysis.
BA

General methods for monitoring convergence of uncertainty estimation

Brooks SP, Gelman A. (1998)

J Comput Graph Stat 1998
SECTOR_PRO

Prognostic Models & Outcomes

Prognostic factors, risk stratification, and outcome modeling references

SA

PSA doubling effect (covariate source)

Schneider CA, et al. (2021)

Eur Urol 2021
Title abbreviated in page; source for PSA doubling effect in survival model.
KA

Gleason score adjustments (covariate source)

Kessel K, et al. (2019)

J Nucl Med 2019
Title abbreviated in page; source for Gleason effect size.
YA

ECOG performance status effect (covariate source)

Yazgan SC, et al. (2025)

Prostate Cancer Prostatic Dis 2025
Title abbreviated in page; source for ECOG effect size.
TA

Prior taxane effect (covariate source)

Telli T, et al. (2023)

Clin Genitourin Cancer 2023
Title abbreviated in page; source for prior taxane effect size.

Signal Lost: No references found.