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治験 NCT06165302(対象:転移性前立腺癌、前立腺癌)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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Exercise in Prostate Cancer
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06165302 は 介入研究 臨床試験 で、転移性前立腺癌、前立腺癌 に関するものです。現在は 募集中 で、2025年10月16日 から開始しています。20 名の参加者 の募集が計画されています。この治験は Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins によって主催され、2030年1月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月17日 です。
概要
The goal of this clinical trial is to learn how exercise intervention affects circulating tumor cells (CTC) in men with advanced prostate cancer. The primary objective is to determine if an exercise intervention decreases CTCs in men with advanced prostate cancer. Participants will have baseline screening assessments, followed by 12 weeks of exercise intervention, and then follow-up assessments 12 weeks after the end of the exercise intervention.
詳細説明
This is a pilot single arm prospective study of personalized exercise training in men with metastatic castration resistant prostate cancer who are being treated with or without oral anti-androgens. The primary objective is to determine if combination of resistance and aerobic exercises lowers CTCs in men with mCRPC. Researchers will assess the rate of conversion from CTC positive to CTC negative in participants at the end of the 12 week exercise intervention. The study will enroll 20 participants onto the trial with the goal of at least 10 participants having blood drawn at both baseline and 12 weeks and completed at least 75% of the prescribed exercise sessions. Participants will undergo follow-up assessments at the end of the 12 week exercise intervention and the study team will monitor participant records for 365 days after the study completion for vital status.
公式タイトル
EPC Trial: Exercise in Prostate Cancer
疾患/病気
転移性前立腺癌前立腺癌その他の研究識別子
- J23147
- IRB00410196 (その他の識別子) (JHM IRB)
NCT番号
開始日
2025-10-16
最終更新日
2025-10-17
終了予定日
2030-01-30
目標参加者数
20
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Exercise Intervention
主目的
その他
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし(非盲検)
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Exercise Intervention Participants will be prescribed an exercise program after completing assessments at baseline. Participants will adhere to the prescribed exercise intervention for 12 weeks and log activity in a physical activity diary. Participants will return to clinic on Week 5 and Week 9 for assessments and adjustment to their exercise prescription as needed. | 運動介入 12 weeks of prescribed exercise intervention. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of participants with negative CTC count | Number of participants with negative CTC count at 12 weeks compared to the baseline | Baseline, 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of participants with change in cell free DNA levels | Number of participants with change in cell free DNA levels from baseline to 12 weeks | Baseline, 12 weeks |
Number of participants with change in Cell free RNA levels | Number of participants with change in cell free RNA levels from baseline to 12 weeks | Baseline, 12 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Men with metastatic prostate adenocarcinoma
- Currently taking androgen deprivation therapy alone or with an oral androgen axis inhibitor (abiraterone, enzalutamide, darolutamide, or apalutamide are permitted) and have been on treatment for at least 3 months
- Elevated (PSA > 1ng/mL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)
- Any number of prior therapies (prior chemo, radium-223, etc.) is allowed
- CTC + according to standard clinical grade laboratory test by androgen receptor isoform splice variant 7 (AR-V7) testing at Hopkins.
- If a bone protective agent is to be started, it should be started at least 2 weeks prior to the onset of exercise intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status <=1
- Clearance by cardiologist if under the current care of a cardiologist (seen in the past 1 year)
- Age <=80 years
- Small cell carcinoma of the prostate
- Unable to participate or monitor exercise compliance due to conditions such as impaired cognition
- Moderate to severe bone pain that limits any activities of daily living, including use of narcotics for prostate cancer related pain
- Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control
- Bone metastases in spine or long bones which, in the eye of the treating physician require referral to radiation oncology or surgery for management due to risk of fracture
- Significant cardiovascular disease or concurrent illness that would make exercise intervention for 12 weeks unsafe. If there is significant cardiovascular disease and the participant is under the care of a cardiologist (seen within the past 1 year), approval of the cardiologist to participate is required.
- Major surgery within the past 4 weeks
試験中央連絡先
連絡先: Rana Sullivan, RN, 410-614-6337, [email protected]
1 1カ国の場所
Maryland
Johns Hopkins University, Baltimore, Maryland, 21287, United States
Niya Research Coordinator, 連絡先, 410-955-1017, [email protected]
募集中