Whole Versus Partial Gland Boost During Prostate SBRT
Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Krishna Gottipati, MS
- 電話番号：4025593518
- メール：krgottipati@unmc.edu
研究連絡先のバックアップ
- 名前：IIT Office Gottipati
- 電話番号：4025590963
- メール：IITOFFICE@unmc.edu
研究場所
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Nebraska
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Omaha、Nebraska、アメリカ、68198
- Fred & Pamela Buffet Cancer Center
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コンタクト：
- Michael Baine, MD, PhD
- 電話番号：(402) 552-2703
- メール：mbaine@unmc.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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).
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External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Grade 2 or Higher Chronic Genitourinary Toxicity
時間枠：From 6 months post-treatment to 2 years post-treatment
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Biochemical Progression-Free Survival
時間枠：From initiation of study treatment to 5 years post-treatment
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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
時間枠：From end of treatment to 6 months post-treatment
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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
時間枠：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
時間枠：From 6 months post-treatment to 5 years post-treatment
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Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains.
|
From 6 months post-treatment to 5 years post-treatment
|
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Chronic Genitourinary Toxicity
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael Baine, MD, PhD、University of Nebraska medicine
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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