A Phase 2 interventional study of Enzalutamide in Prostate Carcinoma Metastatic to the Bone and Castration Resistant Prostate Cancer, sponsored by Pfizer. Completed at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 23 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Drug: Enzalutamide
Also known as: MDV3100, Xtandi
Percentage of Participants With at Least (>=) 1 Responding Bone Lesion Assessed by Total Sodium Fluoride (NaF) Standardized Uptake Value [SUVtotal] at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule
Bone lesion responded: if its change from baseline in SUVtotal is below limit of agreement (LOA, no specific value, based upon test/retest analysis using software). SUVtotal: total NaF uptake,indicated tumor burden across all bone lesions/in individual lesions reflecting bone-metastatic prostate cancer.NaF-3 performed on any of these: 1) prostate-specific antigen (PSA) progression(increase of \>=25% and absolute increase of \>=2.0 ng/mL above nadir); 2) bone progressive disease(PD)(appearance of \>=2 new lesions after screening assessed by technetium Tc 99m medronate \[99mTc-MDP\] bone scintigraphy); 3) soft tissue PD; 4) clinically relevant progression by investigator; 5) at 2 years without progression after treatment initiation. PD, RECIST1.1:\>=20% increase in sum of diameters of target lesions,(reference smallest sum on study, included baseline sum if that is smallest on study),relative increase of 20%,sum of diameters indicated absolute increase of \>=5mm, appearance of \>=1 new lesions.
Time frame: At NaF-3 schedule: at time of PSA, or radiographic(bone or soft tissue), or clinically relevant progression, or at 2years without progression after treatment initiation, whichever occurred first(From first dose of study drug up to maximum of 34.1 months)
Mean Heterogeneity of Response Across All Bone Lesions as Measured by Global Heterogeneity of NaF Standardized Uptake (SUVhetero) Score at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule
Global SUVhetero score:Sum of(SUVmean of each lesion minus global SUVmean of all lesion)\^2/number of lesions,measure of heterogeneity of tumor activity across all bone lesions.SUVmean(mean NaF uptake)indicated average activity of each lesions.Real limits for SUVhetero score ranged:0(minimum) to infinite(maximum).Higher global SUVhetero score:more heterogeneity in bone lesion activity.NaF-3 performed on any of these 1)PSA progression(increase of\>=25% and absolute increase of\>=2.0ng/mL above nadir);2)bone PD(appearance of\>=2 new lesions after screening assessed by 99mTc-MDP bone scintigraphy);3)soft tissue PD(RECIST1.1);4)clinically relevant progression by investigator;5)at 2years without progression after treatment initiation.PD perRECIST1.1:\>=20%increase in sum of diameters of target lesions,(reference smallest sum on study,this included baseline sum if that is smallest on study),relative increase of20%,sum of diameters indicated absolute increase of\>=5mm,appearance of\>=1 new lesions.
Time frame: At NaF-3 schedule: at time of PSA, or radiographic(bone or soft tissue), or clinically relevant progression, or at 2years without progression after treatment initiation, whichever occurred first(From first dose of study drug up to maximum of 34.1 months)
| Milestone | Enzalutamide 160 Milligram (mg) (18F-NaF PET/CT) |
|---|---|
| Started | 23 |
| Completed | 0 |
| Not completed | 23 |
| Withdrew: Transitioned to study-nct02960022 | 5 |
| Withdrew: Death | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Disease progression | 16 |
Bone lesion responded: if its change from baseline in SUVtotal is below limit of agreement (LOA, no specific value, based upon test/retest analysis using software). SUVtotal: total NaF uptake,indicated tumor burden across all bone lesions/in individual lesions reflecting bone-metastatic prostate cancer.NaF-3 performed on any of these: 1) prostate-specific antigen (PSA) progression(increase of \>=25% and absolute increase of \>=2.0 ng/mL above nadir); 2) bone progressive disease(PD)(appearance of \>=2 new lesions after screening assessed by technetium Tc 99m medronate \[99mTc-MDP\] bone scintigraphy); 3) soft tissue PD; 4) clinically relevant progression by investigator; 5) at 2 years without progression after treatment initiation. PD, RECIST1.1:\>=20% increase in sum of diameters of target lesions,(reference smallest sum on study, included baseline sum if that is smallest on study),relative increase of 20%,sum of diameters indicated absolute increase of \>=5mm, appearance of \>=1 new lesions.
| percentage of participants | Enzalutamide 160 mg (18F-NaF PET/CT) |
|---|---|
| Percentage of Participants With at Least (>=) 1 Responding Bone Lesion Assessed by Total Sodium Fluoride (NaF) Standardized Uptake Value [SUVtotal] at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule | 100.0 (84.6 to 100.0) |
Global SUVhetero score:Sum of(SUVmean of each lesion minus global SUVmean of all lesion)\^2/number of lesions,measure of heterogeneity of tumor activity across all bone lesions.SUVmean(mean NaF uptake)indicated average activity of each lesions.Real limits for SUVhetero score ranged:0(minimum) to infinite(maximum).Higher global SUVhetero score:more heterogeneity in bone lesion activity.NaF-3 performed on any of these 1)PSA progression(increase of\>=25% and absolute increase of\>=2.0ng/mL above nadir);2)bone PD(appearance of\>=2 new lesions after screening assessed by 99mTc-MDP bone scintigraphy);3)soft tissue PD(RECIST1.1);4)clinically relevant progression by investigator;5)at 2years without progression after treatment initiation.PD perRECIST1.1:\>=20%increase in sum of diameters of target lesions,(reference smallest sum on study,this included baseline sum if that is smallest on study),relative increase of20%,sum of diameters indicated absolute increase of\>=5mm,appearance of\>=1 new lesions.
| unit on SUVhetero score | Enzalutamide 160 mg (18F-NaF PET/CT) |
|---|---|
| Mean Heterogeneity of Response Across All Bone Lesions as Measured by Global Heterogeneity of NaF Standardized Uptake (SUVhetero) Score at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule | 3.9 ± 3.17 |
Collected over From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enzalutamide 160 mg | 1/23 (4.3%) | 9/23 (39.1%) | 22/23 (95.7%) |
| Event | Enzalutamide 160 mg |
|---|---|
| Mitral valve incompetenceCardiac disorders | 1/23 |
| AstheniaGeneral disorders | 1/23 |
| DiarrhoeaGastrointestinal disorders | 1/23 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/23 |
| CellulitisInfections and infestations | 1/23 |
| Back painMusculoskeletal and connective tissue disorders | 1/23 |
| Laryngeal squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/23 |
| Completed suicidePsychiatric disorders | 1/23 |
| HaematuriaRenal and urinary disorders | 1/23 |
| Urinary retentionRenal and urinary disorders | 1/23 |
| Event | Enzalutamide 160 mg |
|---|---|
| FatigueGeneral disorders | 19/23 |
| FallInjury, poisoning and procedural complications | 6/23 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/23 |
| Back painMusculoskeletal and connective tissue disorders | 6/23 |
| DiarrhoeaGastrointestinal disorders | 5/23 |
| Decreased appetiteMetabolism and nutrition disorders | 4/23 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 4/23 |
| Hot flushVascular disorders | 4/23 |
| HypertensionVascular disorders | 4/23 |
| AstheniaGeneral disorders | 3/23 |
As treated population included all enrolled participants who received any amount of study medication.
| Age, Continuous(years) | Enzalutamide 160 mg (18F-NaF PET/CT) |
|---|---|
| Mean | 72.0 ± 10.07 |
| Sex: Female, Male(Participants) | Enzalutamide 160 mg (18F-NaF PET/CT) |
|---|---|
| Female | 0 |
| Male | 23 |
| Ethnicity (NIH/OMB)(Participants) | Enzalutamide 160 mg (18F-NaF PET/CT) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Enzalutamide 160 mg (18F-NaF PET/CT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer