18 and older, male only, with Castration-Resistant Prostate Carcinoma or Metastatic Malignant Neoplasm in the Bone. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a >= 50% Decline in Prostate-specific Antigen (PSA) ValuePrimary· Baseline to 12 weeks
The percentage of participants with a \>= 50% decline in PSA values will be reported with 95% exact confidence interval. For each participant, percentage decline in PSA values are calculated as 100% times the difference between PSA values taken at baseline and 12 weeks divided by PSA values at baseline. Percentage of participants determined as 100% times the number of participants with \>= 50% decline divided by overall number of participants.
Group
Value
95% CI
Treatment (Enzalutamide)
73.5
55.6 – 87.1
Percentage of Participants With Tumor Protein 53 Gene (TP53) Copy Number Alterations and MutationsPrimary· Baseline to 12 weeks
Evaluate the association between PSA response at 12 weeks after initiating therapy, and TP53 copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with TP53 copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.
Group
Value
95% CI
Responders
28.6
PSA Non-responders
80.0
Percentage of Participants With Phosphatase and Tensin Homologue Gene (PTEN) Copy Number Alterations and MutationsPrimary· Baseline to 12 weeks
Evaluate the association between PSA response at 12 weeks after initiating therapy, and PTEN copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with PTEN copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.
Group
Value
95% CI
Responders
47.6
PSA Non-responders
40.0
Percentage of Participants With Retinoblastoma Gene (RB1) Copy Number Alterations and MutationsPrimary· Baseline to 12 weeks
Evaluate the association between PSA response at 12 weeks after initiating therapy, and RB1 copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with RB1 copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.
Median AR mRNA expression between responders and non-responders.
Group
Value
95% CI
Responders
224.9
± 133.2
Non-responders
201.7
± 201.7
Androgen Receptor Variant 7 (AR-V7) ExpressionPrimary· Baseline to 12 weeks
Median AR-V7 expression between responders and non-responders.
Group
Value
95% CI
Responders
10.4
± 7.2
Non-responders
12.3
± 11.8
Percentage of Participants With Androgen Receptor (AR) Copy Number Alterations and MutationsPrimary· Baseline to 12 weeks
Evaluate the association between PSA response at 12 weeks after initiating therapy, and AR copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with AR copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.
Group
Value
95% CI
Responders
73.7
PSA Non-responders
100.0
Number of Participants With Protein Expression of ARPrimary· Baseline to 12 weeks
The number of participants, responders and non-responders, that were found to have protein expression of AR.
Group
Value
95% CI
Responders
15
PSA Non-responders
6
Androgen Receptor (AR) Activity LevelPrimary· Baseline to 12 weeks
Median Normalized Enrichment Score (NES) AR activity levels of responders and non-responders. Gene Set Enrichment Analysis (GSEA) is used to interpret gene expression data. GSEA enrichment score (ES) reflects the degree to which a gene set (GS) is overrepresented at the top or bottom of a ranked list of genes. ES is calculated by walking down the list, increasing a running-sum statistic when a gene is in the GS and decreasing when it's not. Magnitude of increment depends on correlation of the gene with the phenotype. ES is the max deviation from zero encountered in walking the list. Positive E
Group
Value
95% CI
Responders
2.2
± 3.3
Non-responders
-2.6
± 1.4
Prostate-specific Antigen (PSA) ChangesSecondary· Baseline to up to 5 years
Number of patients who achieved a 50% or greater PSA decline any time after 12 weeks post-baseline.
Group
Value
95% CI
Treatment (Enzalutamide)
25
Percentage of Participants With an Objective ResponseSecondary· Baseline to date of first documented radiographic objective response, assessed up to 1 year
The percentage of participants with an objective response will be reported with 95% exact confidence interval. Objective radiographic response is evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. For each participant, objective response is calculated as 100% times the difference between the sum of measurable target lesio
Group
Value
95% CI
Treatment (Enzalutamide)
63.6
40.7 – 82.8
Progression-free Survival (PFS)Secondary· Time from day 1 of study drug treatment to date of first documented radiographic progression or clinical progression, assessed up to 5 years
Correlations between baseline molecular features and pathways and PFS will be assessed using cox regression model. In addition, Kaplan-Meier plots will be used to graphically illustrate the survival distributions across the strata of categorical molecular predictors.
Group
Value
95% CI
Responders
23.9
10.9 – 33.6
PSA Non-responders
3.7
2.0 – 11.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Median time period for adverse events 14 months (range 2 months to 53 months). Deaths assessed up to 5 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Enzalutamide)
Serious: 6/36 (17%)
Deaths: 2/36
Serious adverse events (15 terms)
Reaction
System
Treatment (Enzalutamide)
Urinary tract infection
Infections and infestations
—
fracture
Injury, poisoning and procedural complications
—
Acute kidney injury
Renal and urinary disorders
—
Anemia
Blood and lymphatic system disorders
—
Atrial fibrillation
Cardiac disorders
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Disease progression
General disorders
—
Heart failure
Cardiac disorders
—
Hematuria
Renal and urinary disorders
—
Hypotension
Vascular disorders
—
Intracranial hemorrhage
Nervous system disorders
—
Encephalopathy
Nervous system disorders
—
Renal and urinary disorders - other, kidney cancer
Renal and urinary disorders
—
Sepsis
Infections and infestations
—
Soft tissue infection
Infections and infestations
—
Other adverse events (34 terms — click to expand)
Reaction
System
Treatment (Enzalutamide)
fatigue
General disorders
—
fall
Injury, poisoning and procedural complications
—
fracture
Injury, poisoning and procedural complications
—
pain
General disorders
—
Musculoskeletal and connective tissue disorder - Other, hip pain
Musculoskeletal and connective tissue disorders
—
Nausea
Gastrointestinal disorders
—
Upper respiratory infection
Infections and infestations
—
dizziness
Nervous system disorders
—
dyspnea
Respiratory, thoracic and mediastinal disorders
—
edema limbs
General disorders
—
Hot flashes
Vascular disorders
—
Stroke
Nervous system disorders
—
Urinary tract infection
Infections and infestations
—
depression
Psychiatric disorders
—
diarrhea
Gastrointestinal disorders
—
Dysgeusia
Nervous system disorders
—
Gynecomastia
Reproductive system and breast disorders
—
Hematuria
Renal and urinary disorders
—
Hypertension
Vascular disorders
—
Hypokalemia
Metabolism and nutrition disorders
—
Insomnia
Psychiatric disorders
—
Nervous system disorders - Other, neuropathy
Nervous system disorders
—
back pain
Musculoskeletal and connective tissue disorders
—
Paresthesia
Nervous system disorders
—
Myalgia
Musculoskeletal and connective tissue disorders
—
Abdominal pain
Gastrointestinal disorders
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
Musculoskeletal and connective tissue disorder - Other, shoulder pain
This phase II trial studies genetic and molecular mechanisms in assessing response in patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Studying samples of tissue and blood in the laboratory from patients with prostate cancer may help doctors better understand castration-resistant prostate cancer. It may also help doctors make improvements in prostate cancer treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07287150 — A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT07226986 — A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI i
· Phase 1, PHASE2
· recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
· Phase 1
· recruiting
NCT07028853 — This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide W
· Phase 3
· recruiting
NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC)
· Phase 2
· recruiting
Other recruiting trials for Castration-Resistant Prostate Carcinoma
Currently open trials in the same condition.
NCT06942104 — Imaging of Solid Tumors Using 18F-TRX
· Phase 1
· recruiting
NCT06632977 — Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
· Phase 2
· recruiting
NCT06305598 — Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration
· Phase 1
· recruiting
NCT06236139 — Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate
· Phase 1, PHASE2
· recruiting
NCT06145633 — Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
Other OHSU Knight Cancer Institute trials
Trials by the same sponsor.
NCT05453851 — A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatme
· Phase 1, PHASE2
· not yet recruiting
NCT07511504 — Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanc
· Phase 2
· not yet recruiting
NCT07434128 — Mammogram Pretreatment With Ulipristal Acetate
· Phase 2
· not yet recruiting
NCT07504835 — GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
· NA
· not yet recruiting
NCT07498517 — Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OHSU Knight Cancer Institute
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02099864.