Whole Versus Partial Gland Boost During Prostate SBRT
8. maj 2026 opdateret af: University of Nebraska
A Phase 2/3 Randomized Trial of Whole Versus Partial Gland Boost During Prostate Stereotactic Body Radiotherapy (SBRT)
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
186
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Krishna Gottipati, MS
- Telefonnummer: 4025593518
- E-mail: krgottipati@unmc.edu
Undersøgelse Kontakt Backup
- Navn: IIT Office Gottipati
- Telefonnummer: 4025590963
- E-mail: IITOFFICE@unmc.edu
Studiesteder
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-
Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Fred & Pamela Buffet Cancer Center
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Kontakt:
- Michael Baine, MD, PhD
- Telefonnummer: (402) 552-2703
- E-mail: mbaine@unmc.edu
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-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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).
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External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
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Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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From 6 months post-treatment to 2 years post-treatment
|
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Grade 2 or Higher Chronic Gastrointestinal Toxicity
Tidsramme: From 6 months post-treatment to 2 years post-treatment
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Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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From 6 months post-treatment to 2 years post-treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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
|
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Acute Genitourinary Toxicity
Tidsramme: From end of treatment to 6 months post-treatment
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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
|
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael Baine, MD, PhD, University of Nebraska medicine
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 (Anslået)
25. juli 2026
Primær færdiggørelse (Anslået)
25. august 2032
Studieafslutning (Anslået)
25. august 2035
Datoer for studieregistrering
Først indsendt
30. april 2026
Først indsendt, der opfyldte QC-kriterier
30. april 2026
Først opslået (Faktiske)
8. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Gland Boost
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