Whole Versus Partial Gland Boost During Prostate SBRT
25 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
186
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Krishna Gottipati, MS
- Telefonnummer: 4025593518
- E-post: krgottipati@unmc.edu
Studera Kontakt Backup
- Namn: IIT Office Gottipati
- Telefonnummer: 4025590963
- E-post: IITOFFICE@unmc.edu
Studieorter
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68198
- Fred & Pamela Buffet Cancer Center
-
Kontakt:
- Michael Baine, MD, PhD
- Telefonnummer: (402) 552-2703
- E-post: mbaine@unmc.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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).
|
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Grade 2 or Higher Chronic Genitourinary Toxicity
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Biochemical Progression-Free Survival
Tidsram: 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
|
|
Acute Gastrointestinal Toxicity
Tidsram: 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.
|
From end of treatment to 6 months post-treatment
|
|
Acute Genitourinary Toxicity
Tidsram: From end of treatment to 6 months post-treatment
|
Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
|
From end of treatment to 6 months post-treatment
|
|
Chronic Gastrointestinal Toxicity
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Michael Baine, MD, PhD, University of Nebraska medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
25 juli 2026
Primärt slutförande (Beräknad)
25 augusti 2032
Avslutad studie (Beräknad)
25 augusti 2035
Studieregistreringsdatum
Först inskickad
30 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
8 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Gland Boost
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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