Whole Versus Partial Gland Boost During Prostate SBRT
25. juni 2026 oppdatert av: University of Nebraska
Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI).
The primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years.
Participants will be followed for up to 5 years after completion of treatment.
Studietype
Intervensjonell
Registrering (Antatt)
186
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Krishna Gottipati, MS
- Telefonnummer: 4025593518
- E-post: krgottipati@unmc.edu
Studer Kontakt Backup
- Navn: IIT Office Gottipati
- Telefonnummer: 4025590963
- E-post: IITOFFICE@unmc.edu
Studiesteder
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68198
- Fred & Pamela Buffet Cancer Center
-
Ta kontakt med:
- Michael Baine, MD, PhD
- Telefonnummer: (402) 552-2703
- E-post: mbaine@unmc.edu
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adults ≥19 years of age
- Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered
- Prostate gland volume <100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)
- PI-RADS 4 or 5 lesion seen on pre-treatment MRI
- IPSS/AUA symptom score less than 16
Exclusion Criteria:
- Prior treatment for prostate cancer
- Prior solid cancer diagnosis within the last 5 years
- Any history of anal or rectal cancer
- Any history of invasive carcinoma of the bladder
- History of prior circumferential resection of the rectum (such as LAR or APR)
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Arm A: boost to prostate alone
Participants assigned to Arm A will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4000 cGy to the clinical target volume (CTV), consisting of the prostate alone without a margin.
Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
|
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
|
|
Eksperimentell: Arm B: boost to dominant intra-prostatic lesion (DIL)
Participants assigned to Arm B will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4500 cGy to the dominant intra-prostatic lesion (DIL).
Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
|
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Grade 2 or Higher Chronic Genitourinary Toxicity
Tidsramme: From 6 months post-treatment to 2 years post-treatment
|
Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
|
From 6 months post-treatment to 2 years post-treatment
|
|
Grade 2 or Higher Chronic Gastrointestinal Toxicity
Tidsramme: From 6 months post-treatment to 2 years post-treatment
|
Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
|
From 6 months post-treatment to 2 years post-treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Biochemical Progression-Free Survival
Tidsramme: From initiation of study treatment to 5 years post-treatment
|
Time from initiation of study treatment to biochemical disease progression or death from any cause.
|
From initiation of study treatment to 5 years post-treatment
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Acute Gastrointestinal Toxicity
Tidsramme: From end of treatment to 6 months post-treatment
|
Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.
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From end of treatment to 6 months post-treatment
|
|
Acute Genitourinary Toxicity
Tidsramme: From end of treatment to 6 months post-treatment
|
Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
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From end of treatment to 6 months post-treatment
|
|
Chronic Gastrointestinal Toxicity
Tidsramme: From 6 months post-treatment to 5 years post-treatment
|
Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains.
|
From 6 months post-treatment to 5 years post-treatment
|
|
Chronic Genitourinary Toxicity
Tidsramme: From 6 months post-treatment to 5 years post-treatment
|
Incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
|
From 6 months post-treatment to 5 years post-treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Michael Baine, MD, PhD, University of Nebraska medicine
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
25. juli 2026
Primær fullføring (Antatt)
25. august 2032
Studiet fullført (Antatt)
25. august 2035
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
30. april 2026
Først lagt ut (Faktiske)
8. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Gland Boost
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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