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Forbedring af livskvaliteten for overlevende af prostatakræft med androgenmangel

18. juni 2026 opdateret af: Shalender Bhasin, MD, Dana-Farber Cancer Institute
Formålet med dette fase II-forsøg er at bestemme effektiviteten og sikkerheden af ​​testosteronerstatningsterapi (TRT) til at forbedre symptomerne på androgenmangel og sundhedsrelateret livskvalitet hos mænd med prostatacancer, som har gennemgået radikal prostatektomi.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Det overordnede mål er at udføre et proof-of-concept dobbeltblindt, placebokontrolleret, parallelgruppe, randomiseret forsøg for at bestemme effektiviteten og sikkerheden af ​​testosteronerstatningsterapi (TRT) til at forbedre symptomerne på androgenmangel (seksuelle symptomer, lave energi og fysisk dysfunktion) og overordnet sundhedsrelateret livskvalitet hos mænd med prostatacancer, som har gennemgået radikal prostatektomi for organlokaliseret sygdom (pT2,N0,M0), Gleason-score < 7 (3+4), som ikke kan påvises PSA (<0,1 ng/ml ved brug af et følsomt PSA-assay) i > 2 år efter radikal prostatektomi, og som har androgenmangel.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

136

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana Farber Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Mænd med prostatacancer, som har Stage pT2, N0, M0 læsioner (begrænset til kirtlen); Kombineret Gleason-score på 7 (3+4 elementer) eller mindre; Præoperativ PSA mindre end 10 ng/ml; Stabilt og ikke-detekterbart PSA-niveau (PSA mindre end 0,1 ng/ml ved brug af et assay, der har en funktionel følsomhed på 0,1 ng/ml) i mindst to år efter radikal prostatektomi.

  • Alder: 40 år og ældre
  • Tilstedeværelse af symptomer relateret til seksuel dysfunktion, træthed/lav vitalitet eller fysisk dysfunktion.
  • Et gennemsnit på to fastende testosteronniveauer tidligt om morgenen, målt ved LC-MS/MS, mindre end 275 mg/dL og/eller frit testosteron ved ligevægtsdialyse <60 pg/ml. midaldrende og ældre mænd med gennemsnitlige testosteronniveauer > 300 ng/dL.
  • Evne og vilje til at give informeret samtykke

Ekskluderingskriterier:

  • Mænd, der har gennemgået strålebehandling
  • Mænd, der modtager androgen-deprivationsterapi, vil blive udelukket.
  • Hæmoglobin <10 g/dL eller >16,5 g/dL
  • Alvorlig ubehandlet søvnapnø
  • Allergi over for sesamolie
  • Ukontrolleret hjertesvigt
  • Myokardieinfarkt, akut koronarsyndrom, revaskulariseringskirurgi eller slagtilfælde inden for 3 måneder
  • Serumkreatinin >2,5 mg/dL; ALT 3x øvre normalgrænse;
  • Hæmoglobin A1c >7,5 % eller diabetes, der kræver insulinbehandling
  • Body mass index (BMI) >40 kg/m2
  • Ubehandlet depression. Personer med depression, som har været på stabil anti-depressiv medicin eller gennemgået CBT i mere end tre måneder er berettigede.
  • Mænd med akse I psykiatrisk lidelse, såsom skizofreni, vil blive udelukket.
  • Forsøgspersoner, der har brugt følgende medicin inden for de seneste 6 måneder: testosteron, DHEA, østrogener, GnRH-analoger, antiandrogener, spironolacton, ketoconazol, rhGH, megestrolacetat, prednison 20 mg dagligt eller tilsvarende doser af andre glukokortikoider i mere end to uger

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Behandlingsarm
Ugentlig IM administration af 100 mg testosteron cypionat i 12 uger.
Medicin: Testosteron Cypionate 100 MG/ML
100 mg testosteron cypionat administreret ved intramuskulær injektion ugentligt i 12 uger.
Andre navne:
  • Depo-Testosteron
Placebo komparator: Kontrolarm
Ugentlig IM administration af placebo i 12 uger.
Medicin: Placebo
Placebo administreret ved intramuskulær injektion ugentligt i 12 uger.
Andre navne:
  • Inaktiv komparator

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Biochemical Recurrence of Prostate Cancer
Tidsramme: the 12-week treatment and the 3-month follow-up
The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.
the 12-week treatment and the 3-month follow-up
Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4
Tidsramme: Week 6, Week 12
The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ questionnaire daily for 7 consecutive days before each visit. The PDQ covers 3 domains:1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.
Week 6, Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in PSA
Tidsramme: Week 12
The secondary safety endpoint is change in PSA levels. Change from baseline in PSA could not be computed because the majority of the participants had undetectable PSA levels at baseline and post-baseline. Here, the number of participants with various PSA levels is reported.
Week 12
Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)
Tidsramme: Week 6, Week 12
The secondary safety endpoint is the change from baseline in lower urinary tract symptoms, ascertained using the International Prostate Symptom Score (IPSS). The IPSS is a validated 8-question survey (7 symptom questions, 1 quality-of-life question) used to assess the severity of lower urinary tract symptoms (LUTS) associated with BPH, ranging from 0-35, with a higher score indicating a more severe negative symptoms.
Week 6, Week 12
Change From Baseline in Hemoglobin
Tidsramme: Week 6, Week 12
The secondary safety endpoint is the change from baseline in hemoglobin levels.
Week 6, Week 12
Change From Baseline in Hematocrit
Tidsramme: Week 6, Week 12
The secondary safety endpoint is the change from baseline in hematocrit levels.
Week 6, Week 12
Number of Participants With Erythrocytosis in the Two Study Arms
Tidsramme: Week 12
The secondary safety endpoint is the number of participants with erythrocytosis (confirmed hemoglobin > 18.0 g/dL) in the two study arms.
Week 12
Number of Participants With Clinical Prostate Cancer Recurrence in the Two Study Arms
Tidsramme: Week 12
The secondary safety endpoint is the number of participants with clinical prostate cancer recurrence in the two study arms.
Week 12
Change From Baseline in Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire
Tidsramme: Week 6, Week 12
The secondary efficacy endpoint is sexual desire, assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire. The DISF evaluates an individual's sexual health across five primary domains: sexual cognition/fantasy, arousal, behavior/experience, orgasm, and sexual drive/relationship. The Sexual Desire (SD) subset assesses an individual's subjective libido and frequency of sexual drive. The Sexual Desire score can range from 0 to 33, with a higher score indicating more sexual desire.
Week 6, Week 12
Change in Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire.
Tidsramme: Week 6, Week 12
The secondary efficacy endpoint is erectile function will be assessed by the International Index of Erectile Function (IIEF) Questionnaire. The IIEF is a 15-item questionnaire that covers 4 domains of sexual function: erectile function, sexual desire, orgasmic function, and intercourse satisfaction. Each question has a potential score of 0 to 5 for a maximal score of 75 for the entire scale. Our focus in this study is on erectile function domain score, which can range from 0 to 30, lower scores indicating poor erectile function, and higher score indicating better erectile function.
Week 6, Week 12
Change in Energy Level, Assessed Using the Hypogonadism Energy Diary (HED)
Tidsramme: Week 6, Week 12
The secondary efficacy endpoint is energy level, assessed using the Hypogonadism Energy Diary (HED). The total HED scale score is the sum of each of the six item weekly scores, with higher scores corresponding to greater energy level. The HED total score is linearly transformed to a scale of 0-100. Lower scores indicate lower energy (or more tiredness) and higher scores indicate more energy (less tiredness).
Week 6, Week 12
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS)
Tidsramme: Week 6, Week 12
Mood and well-being will be assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report measure to assess positive affect (PA) and negative affect (NA), with scores ranging from 10 to 50 for both the PA score and the NA score. For the PA score (10-50), higher scores represent higher levels of positive emotions, engagement, and enthusiasm. For the NA score (10-50), higher scores indicate higher levels of negative engagement, distress, and anxiety.
Week 6, Week 12
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC)
Tidsramme: Week 6, Week 12
The secondary efficacy endpoint is change from baseline in prostate cancer-related quality of life measured using the hormonal and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). Expanded Prostate Cancer Index Composite Instrument (EPIC-26) for Measuring Health-Related Quality of Life Among Prostate Cancer Survivors EPIC QOL is a 26-item questionnaire that assesses quality of life in 5 domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domain scores. All domains for EPIC-26 are reported on a 0 to 100 score, with higher scores representing favorable Health-Related Quality of Life (HRQOL).
Week 6, Week 12
Change From Baseline in Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10)
Tidsramme: Week 6, Week 12
The secondary efficacy endpoint is change from baseline self-reported physical function, assessed using the physical function component of MOS SF-36 (PF10). The PF-10 (Physical Functioning Scale) is the 10-item subscale within the MOS SF-36 assessing the extent to which health limits physical activities, such as self-care, walking, and lifting. Scores range from 0 to 100, where higher numbers mean better physical function and fewer limitations.
Week 6, Week 12
Change From Baseline in Performance-based Physical Function, Assessed by Measuring Loaded Stair Climbing Power
Tidsramme: Week 12
The secondary efficacy endpoint is change from baseline in performance-based physical function, assessed by measuring loaded stair climbing power.
Week 12
Change From Baseline in Chest Press Strength
Tidsramme: Week 12
The secondary efficacy endpoint is the change from baseline in Chest Press Max weight
Week 12
Change From Baseline in Leg Press Strength
Tidsramme: Week 12
The secondary efficacy endpoint is the change from baseline in Leg Press Max weight
Week 12
Change in Aerobic Capacity (VO2peak) Achieved During Cardiopulmonary Exercise Testing
Tidsramme: Week 12
The secondary efficacy endpoint is aerobic capacity (VO2peak) achieved during cardiopulmonary exercise testing.
Week 12
Change in Lean Body Mass
Tidsramme: Week 12
Change from baseline in whole body, appendicular, and trunk lean tissue mass measured using dual energy X-ray absorptiometry (DXA).
Week 12
Change in Fat Body Mass
Tidsramme: Week 12
Change from baseline in whole body, appendicular, and trunk fat tissue mass measured using dual energy X-ray absorptiometry (DXA).
Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dana-Farber Cancer Institute

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Shalender Bhasin, MD, Brigham and Women's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. marts 2019

Primær færdiggørelse (Faktiske)

16. maj 2025

Studieafslutning (Faktiske)

16. juli 2025

Datoer for studieregistrering

Først indsendt

2. oktober 2018

Først indsendt, der opfyldte QC-kriterier

22. oktober 2018

Først opslået (Faktiske)

23. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. januar 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-733
  • 5R01AG060539-05 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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