前立腺がん疾患管理における非侵襲性バイオマーカー
This study is an observational retrospective/ prospective study with diagnosed low/intermediate risk (no-surgery) & high risk (surgery) prostate cancer that are eligible and willing to undergo standard of care (SOC) assessment, annually along with biopsies, bio-fluid collection. Participants will obtain genomic and histological evaluation on their biopsied samples. Study follows SOC collection with additional body fluid collection (blood, urine). Biopsy/surgery will not require additional sample collection
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Florida
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Tampa、Florida、アメリカ、33612
- Moffitt Cancer Center
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-
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
サンプリング方法
調査対象母集団
Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to tissue samples).
説明
Inclusion Criteria:
- Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples).
- No-Surgery (Intermediate risk) group: patients diagnosed with pre-biopsy mpMRI, blood plasma: the biopsy must consist of a pathological diagnosis with a Gleason pattern score.
- Surgery (High risk) group: patients who had radical prostatectomy (RP) with (or with-out) mpMR imaging, bio fluids available for research will be accrued for this group. We follow the NCCN recommendations for high-risk (Unfavorable intermediate risk or High-risk) groups inclusion and follow-up criteria (58, 89, 90).
- ≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment.
- Age 35 through 85 years.
- Zubrod/ECOG performance status <2;
- Ability to understand and willingness to sign a written informed consent document.
- Patients who agree to have a multiparametric MRI with targeted/template biopsy.
- Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
- Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H&E slides, IHC slides).
- Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest.
Exclusion Criteria:
- Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
- No prior pelvic radiotherapy
- No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
- No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or > Bilateral hip replacement.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Intermediate risk group (no-surgery)
Participants diagnosed with pre-biopsy mpMRI. |
Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC) |
|
High-risk group (surgery)
Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging. |
Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC) |
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 |
|---|---|---|
|
Disease Progression
時間枠：Up to 3 years
|
Progression will be defined according to the National Comprehensive Cancer Network (NCCN) clinical guidelines. Intermediate risk group (no-surgery): Evaluation of targeted lesion indicates any one of the following: a) Gleason grade group of 2 or 3 (Gleason Score: 3+4 or 4+3), b) re-biopsy of lesion results in higher Gleason grade, initial GS 3+3 becomes a 3+4 or higher and c) secondary end point include clinical progression assessed by radiological progression (increased PIRADS score) and/or serum progression (PSA increase). High risk group (surgery): Participants who undergo prostatectomy as standard of care recommendation, following the NCCN guidelines. Participants in this group fall under these clinical characteristics: a) unfavorable intermediate-risk: biopsies with GS 4+3 or higher, b) high risk for prostate cancer progression: biopsies with GS 4+4 or greater or cT3 or greater disease, c) Progression following treatment, increase in PSA ( |
Up to 3 years
|
協力者と研究者
捜査官
- 主任研究者：Yoganand Balagurunathan, PhD、Moffitt Cancer Center
- 主任研究者：Julio Pow-Sang, MD、Moffitt Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MCC-22098
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
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