POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions (PRISM)
Targeting the Gray Zone: Early Detection of Clinically Significant Prostate Cancer in PI-RADS 3 Patients Using PET Imaging With an 18F-Labeled Radiohybrid PSMA-Targeted Imaging Agent
This prospective, multicenter diagnostic accuracy study will evaluate whether POSLUMA (flotufolastat F 18) PET/MRI or PET/CT can detect clinically significant prostate cancer, defined as Gleason score 7 or higher, in adult men with PI-RADS 3 lesions on recent multiparametric MRI and a clinical indication for prostate biopsy. Participants will undergo a research-only POSLUMA PET scan before targeted and systematic prostate biopsy. PET imaging metrics and clinical variables will be compared with histopathology. Research PET results will not be used to guide clinical management or replace standard diagnostic procedures.
調査の概要
詳細な説明
Men aged 18 years or older with a PI-RADS 3 lesion identified on multiparametric MRI within the prior 4 weeks and a clinical indication for prostate biopsy will be consecutively enrolled. After written informed consent, participants will undergo POSLUMA PET/MRI or PET/CT. POSLUMA will be administered as an intravenous bolus at 296 MBq (8 mCi), and imaging will begin approximately 60 minutes after administration. PET-derived metrics, including SUVmax, PRIMARY score, lesion-to-background ratio, and lesion volume, will be recorded. MRI features and clinical parameters, including PSA, PSA density, and free-to-total PSA ratio, may also be collected.
The reference standard will be histopathology from targeted biopsy of the PI-RADS 3 lesion together with systematic prostate biopsy. Diagnostic performance will be evaluated using lesion-level area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and negative predictive value. The study will also estimate biopsy avoidance and missed clinically significant prostate cancer rates and explore multivariable models combining PET, MRI, and clinical variables. Participants should not expect direct clinical benefit, and the research PET result will not alter biopsy decisions or other standard care.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xiaowei Hong
- 電話番号：702-433-6944
- メール：adeline.hong@simonmed.com
研究場所
-
-
Arizona
-
Avondale、Arizona、アメリカ、85392
- SimonMed Imaging - Akos
-
コンタクト：
- Xiaowei Hong
- 電話番号：86+15821075453
- メール：adeline.hong@simonmed.com
-
Chandler、Arizona、アメリカ、85224
- SimonMed Imaging - Chandler South
-
コンタクト：
- Xiaowei Hong
- 電話番号：86+15821075453
- メール：adeline.hong@simonmed.com
-
Mesa、Arizona、アメリカ、85206
- SimonMed Imaging - Greenfield
-
コンタクト：
- Xiaowei Hong
- 電話番号：86+15821075453
- メール：adeline.hong@simonmed.com
-
Phoenix、Arizona、アメリカ、85004
- SimonMed Imaging - Central Phoenix
-
コンタクト：
- Xiaowei Hong
- 電話番号：86+15821075453
- メール：adeline.hong@simonmed.com
-
Scottsdale、Arizona、アメリカ、85254
- SimonMed Imaging - Kierland
-
コンタクト：
- Xiaowei Hong
- 電話番号：86+15821075453
- メール：adeline.hong@simonmed.com
-
Surprise、Arizona、アメリカ、85374
- SimonMed Imaging - Surprise Stadium Village
-
コンタクト：
- Xiaowei Hong
- 電話番号：86+15821075453
- メール：adeline.hong@simonmed.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male, age 18 years or older
- PI-RADS 3 lesion diagnosed by multiparametric MRI within the past 4 weeks
- Clinical indication for prostate biopsy
- Undergoing targeted biopsy and systematic biopsy as part of the routine clinical pathway
- Able to provide written informed consent
Exclusion Criteria:
- Prior diagnosis or treatment of prostate cancer
- PI-RADS 4 or 5 lesion
- Negative MRI, defined as PI-RADS 1 or 2
- Contraindication to PSMA PET or prostate biopsy
- Contraindication to both MRI and CT
- Any medical condition that may interfere with study procedures
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：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：POSLUMA PET Diagnostic Imaging
Participants undergo one research-only POSLUMA PET/MRI or PET/CT before targeted and systematic prostate biopsy. |
Participants undergo research-only PSMA PET/MRI or PET/CT using POSLUMA (flotufolastat F 18) before clinically indicated prostate biopsy. POSLUMA is administered intravenously at 296 MBq (8 mCi), with PET imaging beginning approximately 60 minutes after administration. PET imaging findings are compared with histopathology from targeted and systematic prostate biopsy.
他の名前：
|
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 |
|---|---|---|
|
Diagnostic accuracy of POSLUMA PET for clinically significant prostate cancer
時間枠：From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
Lesion-level area under the receiver operating characteristic curve for POSLUMA PET metrics, including SUVmax and PRIMARY score, using biopsy histopathology and clinically significant prostate cancer defined as Gleason score 7 or higher as the reference standard. |
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of POSLUMA PET
時間枠：From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
Lesion-level sensitivity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard. |
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
|
Specificity of POSLUMA PET
時間枠：From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
Lesion-level specificity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard. |
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
|
Positive predictive value of POSLUMA PET
時間枠：From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
Positive predictive value for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard. |
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
|
Negative predictive value of POSLUMA PET
時間枠：From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
Negative predictive value for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard. |
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
|
|
Potential biopsy avoidance rate
時間枠：At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
|
Percentage of participants with low PSMA uptake who would be classified as potentially able to avoid biopsy under the study's exploratory imaging criteria. |
At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
|
|
Missed clinically significant prostate cancer rate
時間枠：At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
|
Proportion of clinically significant prostate cancer cases associated with low PSMA uptake under the study's exploratory imaging criteria. |
At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
|
|
Performance of a multivariable diagnostic model
時間枠：After completion of imaging, biopsy, and histopathology data collection, through December 2028
|
Model performance when combining PSMA PET metrics with clinical and imaging variables such as PSA, PSA density, free-to-total PSA ratio, ADC, lesion volume, and other protocol-specified variables. |
After completion of imaging, biopsy, and histopathology data collection, through December 2028
|
協力者と研究者
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TUNIRB000379
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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