Nutrition and Prostate Cancer
5. Mai 2021 aktualisiert von: Yale University
Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a parallel group, double-blind, randomized clinical trial with two arms. The primary aim is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with prostate cancer. This study has 1 primary aim and 3 (1a thru 1c) sub aims. Aim 1 is to assess the effect of Fermented Soy (QC) on PSA (prostate specific antigen) In parallel, in Aims 1a-1c will assess tumor-specific effects of QC:
Aim 1a: Identifying the anti-tumor effects of QC. This will be done by culturing multiple human cancer cell lines with QC at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence.
Aim 1b: Identify a hierarchy of tumors that are responsive to QC. From the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects.
Aim 1c: Investigate the signaling pathways in tumor cells that are modified by QC. To do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include P53 and P21 activation pathways.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
19
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06520
- Yale University
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New London, Connecticut, Vereinigte Staaten, 06320
- Yale New Haven Health- Lawrence + Memorial Hospital
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Rhode Island
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Wakefield, Rhode Island, Vereinigte Staaten, 02879
- South County Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
Inclusion Criteria:
- Histologically verified Prostate Cancer (at any stage)
- Scheduled to be treated by radical prostatectomy within the next 4-10 weeks
- Understanding and willingness to provide consent
Exclusion Criteria:
- Previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride)
- History of hormone dependent malignancies
- Concomitant thyroid disease or currently taking thyroid hormone replacement medication
- Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits
- Current or past history of any liver or pancreas disease
- History of allergy or hypersensitivity to soy-containing products
- Malabsorption conditions that might interfere with absorption of the investigational product
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intervention
Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP).
Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
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Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP).
Time can be between 4 and 10 weeks.
Andere Namen:
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Placebo-Komparator: Placebo
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP).
Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
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A placebo compliment to the active intervention with identical packaging and labeling will be used.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Prostate-specific Antigen (PSA)
Zeitfenster: Greater than or equal to 4 weeks (up to 10 weeks)
|
The PSA test measures the level of PSA in a man's blood.
For this test, a blood sample is sent to a laboratory for analysis.
The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL.
Interpretation of these scores is also based on the age of the inidividual.
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Greater than or equal to 4 weeks (up to 10 weeks)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gleason Score
Zeitfenster: Greater than or equal to 4 weeks (up to 10 weeks)
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Pathological investigation of the removed prostate gland will include the assessment of biopsy-proven, index prostate cancer lesion will lead to the analysis of any modulation of PCa grade (Gleason score) compared to preoperative biopsies.
The Gleason Score is interpreted as follows: 3+4 (Prognosis = Good), 4+3 (Prognosis = Likely to Spread), 8 - 10 (Prognosis = Likely to Spread Rapidly).
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Greater than or equal to 4 weeks (up to 10 weeks)
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PCa Tissue Telomeric DNA Length
Zeitfenster: Greater than or equal to 4 weeks (up to 10 weeks)
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Analysis of telomere length in research samples of human peripheral blood mononuclear cells reveals that telomere length decreases with increased replication of cells, reflecting the replicative history of those cells.
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Greater than or equal to 4 weeks (up to 10 weeks)
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Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change
Zeitfenster: Baseline to final visit (up to 10 weeks)
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Post surgical/post intervention CAPRA score will be used for comparison with baseline (screening) value.
The CAPRA score can range from 0 to 10 where: a score of 0 to 2 indicates low-risk, 3 to 5 indicates intermediate-risk, and 6 to 10 indicates high-risk.
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Baseline to final visit (up to 10 weeks)
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Cell Cycle Progression Score
Zeitfenster: Greater than or equal to 4 weeks (up to 10 weeks)
|
Assessment of prostate cancer mRNA can be determined from PCa tissue.
Cell cycle progression score assessment of PCa mRNA is a novel RNA expression-based assay that directly measures tumor cell growth characteristics in order to stratify patients with localized PCa according to disease aggressiveness.
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Greater than or equal to 4 weeks (up to 10 weeks)
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Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
Zeitfenster: Greater than or equal to 4 weeks (up to 10 weeks)
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Quality of life assessment for men with PCa will be assessed with the Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©).
The FACT-P contains 39 items that use a 0-4 rating scale.
The highest possible score is 156 (lowest possible score = 0).
The total score is an indication of overall quality of life where the higher scores indicate better quality of life.
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Greater than or equal to 4 weeks (up to 10 weeks)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
21. November 2018
Primärer Abschluss (Tatsächlich)
14. Dezember 2019
Studienabschluss (Tatsächlich)
14. Dezember 2019
Studienanmeldedaten
Zuerst eingereicht
9. Mai 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Mai 2018
Zuerst gepostet (Tatsächlich)
22. Mai 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Mai 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Mai 2021
Zuletzt verifiziert
1. Mai 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2000020868
Plan für individuelle Teilnehmerdaten (IPD)
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Unentschieden
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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