Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
19. mars 2018 oppdatert av: Memorial Sloan Kettering Cancer Center
Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer.
The study is also looking at how useful focal brachytherapy will be in treating prostate cancer.
Additionally, the investigators would like to see how this type of treatment impacts quality of life.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
3
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New Hyde Park, New York, Forente stater, 11040
- North Shore LIJ
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New York, New York, Forente stater, 10065
- Memorial Sloan Kettering Cancer Center
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Texas
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Houston, Texas, Forente stater, 77030
- MD Anderson Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
- Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostate cancer clinical stage T1c-T2a
- PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
- MRI evidence of one-sided disease performed within 3 months of registration
- Prostate size <60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
- Minimum of 10 biopsy cores
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
- Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
- Minimum of 12 biopsy cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
Subject Exclusion Criteria:
- Medically unfit for anesthesia
- Evidence or suspicion of extracapsular extension on MRI
- IPSS score > 18
- Unable to receive MRI
- Prior radiotherapy for the current disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
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A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions.
Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment.
The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125).
The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life.
The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To Assess the Late Toxicity Outcomes
Tidsramme: 6 months to 2 years
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focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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6 months to 2 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To Evaluate the Local Tumor Control After Focal Brachytherapy
Tidsramme: 12 and 24 months
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as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered.
"All negative" means no prostate cancer;
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12 and 24 months
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To Evaluate the Change From Baseline in QOL Indicators
Tidsramme: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
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Following focal brachytherapy in patients with early stage low volume localized prostate cancer.
The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ
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baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
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To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
Tidsramme: 2 years
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Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined.
Post-treatment biopsy outcome is defined as a binary variable: positive and negative.
We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy.
The correlation will be assessed by a Fisher exact test.
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2 years
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. mai 2011
Primær fullføring (Faktiske)
6. oktober 2017
Studiet fullført (Faktiske)
6. oktober 2017
Datoer for studieregistrering
Først innsendt
16. mai 2011
Først innsendt som oppfylte QC-kriteriene
16. mai 2011
Først lagt ut (Anslag)
17. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. oktober 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mars 2018
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-056
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