Dataset Information

Vitamin D3 supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance.

ABSTRACT:

Context

We wanted to investigate vitamin D in low-risk prostate cancer.

Objectives

The objective of the study was to determine whether vitamin D(3) supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen (PSA) or in the rate of progression.

Design

In this open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.

Setting

All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, both in Charleston, SC.

Patients and other participants

All subjects had a diagnosis of low-risk prostate cancer. Fifty-two subjects were enrolled in the study, 48 completed 1 yr of supplementation, and 44 could be analyzed for both safety and efficacy objectives.

Intervention

The intervention included vitamin D(3) soft gels (4000 IU).

Main outcome measures

Adverse events were monitored throughout the study. PSA serum levels were measured at entry and every 2 months for 1 yr. Biopsy procedures were performed before enrollment (for eligibility) and after 1 yr of supplementation.

Results

No adverse events associated with vitamin D(3) supplementation were observed. No significant changes in PSA levels were observed. However, 24 of 44 subjects (55%) showed a decrease in the number of positive cores or decrease in Gleason score; five subjects (11%) showed no change; 15 subjects (34%) showed an increase in the number of positive cores or Gleason score.

Conclusion

Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D(3) supplementation at 4000 IU/d.

SUBMITTER: Marshall DT

PROVIDER: S-EPMC3387395 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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Publications

Vitamin D3 supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance.

Marshall David T DT Savage Stephen J SJ Garrett-Mayer Elizabeth E Keane Thomas E TE Hollis Bruce W BW Horst Ronald L RL Ambrose Linda H LH Kindy Mark S MS Gattoni-Celli Sebastiano S

The Journal of clinical endocrinology and metabolism 20120416 7

<h4>Context</h4>We wanted to investigate vitamin D in low-risk prostate cancer.<h4>Objectives</h4>The objective of the study was to determine whether vitamin D(3) supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen (PSA) or in the rate of progression.<h4>Design</h4>In this open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.<h4>Setting</h4>All subjects were enrolled throug ...[more]

PMID: 22508710

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Project description:BackgroundThe number of cores to be obtained in targeted biopsy (TB) is important. This study aimed to evaluate the TB outcomes in suspicious prostate lesions classified according to the Prostate Imaging Reporting and Data System (PI-RADS) and to determine the ideal number of biopsy cores per lesion.MethodsThis retrospective study included patients who underwent multiparametric magnetic resonance imaging-guided fusion prostate biopsy owing to increased serum prostate-specific antigen (PSA) levels and suspicious digital rectal examination outcomes in our institute. Patients with PI-RADS <3 lesions, PSA levels >10 ng/ml, and a prior diagnosis of prostate cancer (PCa) (active surveillance) were excluded from the study. The number of biopsy cores to be obtained from each lesion was determined by the clinician.ResultsThe study included a total of 418 patients and 684 lesions. Among PI-RADS 3 lesions, clinically significant PCa (sPCa) detection rate was similar in the lesions from which 2 and 3 cores were obtained (9.1% and 10.0%, respectively), whereas it was relatively higher in the lesions from which 4 biopsy cores were obtained (18.5%). Among PI-RADS 4 lesions, sPCa detection rate was similar in the lesions from which 3 and 4 cores were obtained (35.6% and 32.3%, respectively), whereas it was relatively lower in the lesions from which 2 biopsy cores were obtained (17.9%). Among PI-RADS 5 lesions, however, sPCa detection rate was similar in the lesions from which 2, 3, or 4 cores were obtained (47.6%, 46.0%, 48.9%, respectively).ConclusionThe results indicated that the ideal number of cores to be obtained from each suspicious lesion in TB depends on the characteristics of the lesions. Accordingly, while obtaining 2-3 biopsy cores could be adequate in PI-RADS 4 and 5 lesions, which have a serious risk of cancer, a minimum of 4 biopsy cores should be obtained from PI-RADS 3 lesions to ensure accurate histopathological results.Clinical trial number (ClinicalTrials.gov)NCT03936296.

Project description:SignificanceNeedle biopsy (NB) procedures are important for the initial diagnosis of many types of cancer. However, the possibility of NB specimens being unable to provide diagnostic information, (i.e., non-diagnostic sampling) and the time-consuming histological evaluation process can cause delays in diagnoses that affect patient care.AimWe aim to demonstrate the advantages of this label-free multimodal nonlinear optical imaging (NLOI) technique as a non-destructive point-of-procedure evaluation method for NB tissue cores, for the visualization and characterization of the tissue microenvironment.ApproachA portable, label-free, multimodal NLOI system combined second-harmonic generation (SHG) and third-harmonic generation and two- and three-photon autofluorescence (2PF, 3PF) microscopy. It was used for intraoperative imaging of fresh NB tissue cores acquired during canine cancer surgeries, which involved liver, lung, and mammary tumors as well as soft-tissue sarcoma; in total, eight canine patients were recruited. An added tissue culture chamber enabled the use of this NLOI system for longitudinal imaging of fresh NB tissue cores taken from an induced rat mammary tumor and healthy mouse livers.ResultsThe intraoperative NLOI system was used to assess fresh canine NB specimens during veterinary cancer surgeries. Histology-like morphological features were visualized by the combination of four NLOI modalities at the point-of-procedure. The NLOI results provided quantitative information on the tissue microenvironment such as the collagen fiber orientation using Fourier-domain SHG analysis and metabolic profiling by optical redox ratio (ORR) defined by 2PF/(2PF + 3PF). The analyses showed that the canine mammary tumor had more randomly oriented collagen fibers compared to the tumor margin, and hepatocarcinoma had a wider distribution of ORR with a lower mean value compared to the liver fibrosis and the normal-appearing liver. Moreover, the loss of metabolic information during tissue degradation of fresh murine NB specimens was shown by overall intensity decreases in all channels and an increase of mean ORR from 0.94 (standard deviation 0.099) to 0.97 (standard deviation 0.077) during 1-h longitudinal imaging of a rat mammary tumor NB specimen. The tissue response to staurosporine (STS), an apoptotic inducer, from fresh murine liver NB specimens was also observed. The mean ORR decreased from 0.86 to 0.74 in the first 40 min and then increased to 0.8 during the rest of the hour of imaging, compared to the imaging results without the addition of STS, which showed a continuous increase of ORR from 0.72 to 0.75.ConclusionsA label-free, multimodal NLOI platform reveals microstructural and metabolic information of the fresh NB cores during intraoperative cancer imaging. This system has been demonstrated on animal models to show its potential to provide a more comprehensive histological assessment and a better understanding of the unperturbed tumor microenvironment. Considering tissue degradation, or loss of viability upon fixation, this intraoperative NLOI system has the advantage of immediate assessment of freshly excised tissue specimens at the point of procedure.

Project description:BACKGROUND:Low 25-hydroxyvitamin D (25OHD) levels (<?75 nmol/l) are inversely associated with anemia prevalence. Since anemia and low 25OHD levels are common in patients with heart failure (HF), we aimed to investigate whether vitamin D supplementation can reduce anemia prevalence in advanced HF. METHODS:EVITA (Effect of Vitamin D on Mortality in Heart Failure) is a randomized, placebo-controlled clinical trial in patients with initial 25OHD levels <?75 nmol/l. Participants received either 4000 IU vitamin D3 daily or a matching placebo for 36 months. A total of 172 patients (vitamin D group: n?=?85; placebo group: n?=?87) were investigated in this pre-specified secondary data analysis. Hemoglobin (Hb) and other hematological parameters were measured at baseline and study termination. Assessment of between-group differences in anemia prevalence and Hb concentrations was performed at study termination, while adjusting for baseline differences. RESULTS:In the vitamin D and placebo group, baseline proportions of patients with anemia (Hb?<?12.0 g/dL in females and <?13.0 g/dL in males) were 17.2% and 10.6%, respectively (P?=?0.19). At study termination, the proportion of patients with anemia in the vitamin D and placebo groups was 32.2% and 31.8%, respectively (P?>?0.99). There was no between-group difference in change in the Hb concentrations (-?0.04 g/dL [95%CI:-0.53 to 0.45 g/dL]; P?=?0.87). Results regarding anemia risk and Hb concentrations were similar in the subgroup of patients with chronic kidney disease (vitamin D group: n?=?26; placebo group: n?=?23). Moreover, results did not differ substantially when data analysis was restricted to patients with deficient baseline 25OHD levels. CONCLUSIONS:A daily vitamin D supplement of 4000 IU did not reduce anemia prevalence in patients with advanced HF. Data challenge the clinical relevance of vitamin D supplementation to increase Hb levels. TRIAL REGISTRATION:The study was registered at EudraCT (No. 2010-020793-42) and clinicaltrials.gov ( NCT01326650 ).

Project description:BackgroundNumerous studies have shown that magnetic resonance imaging (MRI)-targeted biopsy approaches are superior to traditional systematic transrectal ultrasound guided biopsy (TRUS-Bx). The optimal number of biopsy cores to be obtained per lesion identified on multiparametric MRI (mpMRI) images, however, remains a matter of debate. The aim of this study was to evaluate the incremental value of additional biopsy cores in an MRI-targeted "in-bore"-biopsy (MRI-Bx) setting.Patients and methodsTwo hundred and forty-five patients, who underwent MRI-Bx between June 2014 and September 2021, were included in this retrospective single-center analysis. All lesions were biopsied with at least five biopsy cores and cumulative detection rates for any cancer (PCa) as well as detection rates of clinically significant cancers (csPCa) were calculated for each sequentially labeled biopsy core. The cumulative per-core detection rates are presented as whole numbers and as proportion of the maximum detection rate reached, when all biopsy cores were considered. CsPCa was defined as Gleason Score (GS) ≥ 7 (3 + 4).ResultsOne hundred and thirty-two of 245 Patients (53.9%) were diagnosed with prostate cancer and csPCa was found in 64 (26.1%) patients. The first biopsy core revealed csPCa/ PCa in 76.6% (49/64)/ 81.8% (108/132) of cases. The second, third and fourth core found csPCa/ PCa not detected by previous cores in 10.9% (7/64)/ 8.3% (11/132), 7.8% (5/64)/ 5.3% (7/132) and 3.1% (2/64)/ 3% (4/132) of cases, respectively. Obtaining one or more cores beyond the fourth biopsy core resulted in an increase in detection rate of 1.6% (1/64)/ 1.5% (2/132).ConclusionWe found that obtaining five cores per lesion maximized detection rates. If, however, future research should establish a clear link between the incidence of serious complications and the number of biopsy cores obtained, a three-core biopsy might suffice as our results suggest that about 95% of all csPCa are detected by the first three cores.

Dataset Information

Vitamin D3 supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance.

Context

Objectives

Design

Setting

Patients and other participants

Intervention

Main outcome measures

Results

Conclusion

Publications

Vitamin D3 supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance.

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