前立腺癌の積極的監視中の ProstAtak®免疫療法のランダム化比較試験 (ULYSSES)
新たに診断された前立腺癌の積極的な監視中に投与された AdV-tk + バラシクロビルのランダム化比較試験
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Colorado
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Golden、Colorado、アメリカ、80401
- Foothills Urology
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Illinois
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Chicago、Illinois、アメリカ、60637
- The University of Chicago
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Chicago、Illinois、アメリカ、60612
- Jesse Brown VA Medical Center
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Louisiana
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New Orleans、Louisiana、アメリカ、70119
- Southeast Louisiana Veterans Health Care System
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Maryland
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Bethesda、Maryland、アメリカ、20889
- Walter Reed National Military Medical Center
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Missouri
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Kansas City、Missouri、アメリカ、64128
- Kansas City VA Medical Center
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Nevada
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Reno、Nevada、アメリカ、89502
- Sierra Nevada Health Care System VA
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
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New York
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North Hills、New York、アメリカ、11042
- Advanced Radiation Centers of New York (Integrated Medical Professionals)
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Syracuse、New York、アメリカ、13210
- Associated Medical Professionals of NY, PLLC
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Ohio
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Middleburg Heights、Ohio、アメリカ、44130
- Southwest Urology, Clinical Research Solutions
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- Oklahoma City VA Healthcare System
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Oregon
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Portland、Oregon、アメリカ、97239
- VA Portland Health Care System
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Springfield、Oregon、アメリカ、97477
- Oregon Urology Insitute
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Pennsylvania
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Lancaster、Pennsylvania、アメリカ、17604
- Lancaster Urology
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Pittsburgh、Pennsylvania、アメリカ、15212
- Allegheny Health Network-Triangle Urological Group
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South Carolina
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Charleston、South Carolina、アメリカ、29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Texas
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San Antonio、Texas、アメリカ、78229-4404
- San Antonio VA Healthcare System
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The Woodlands、Texas、アメリカ、77384
- Woodland Center
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Tomball、Texas、アメリカ、77375
- Texas Urology Specialists
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Virginia
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Richmond、Virginia、アメリカ、23249
- Hunter Holmes McGuire VA Medical Center
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Salem、Virginia、アメリカ、24153
- Salem VA Medical Center
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Mexico City、メキシコ
- Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
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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
説明
Inclusion Criteria include:
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Histologically confirmed adenocarcinoma of the prostate
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Patients choosing active surveillance
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Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
- NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
- NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
- High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
- Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
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Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
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ECOG Performance status 0-2
Exclusion Criteria include:
- Active liver disease, including known cirrhosis or active hepatitis
- Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV+ patients
- Regional lymph node involvement or distant metastases
- Other current malignancy (except squamous or basal cell skin cancers)
- Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
- Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
- Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
- Patients who had or plan to use ADT or have history of an orchiectomy.
- Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
- Known sensitivity or allergic reactions to acyclovir or valacyclovir
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
他の名前：
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. |
|
プラセボコンパレーター：Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir |
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection. Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. |
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 |
|---|---|---|
|
Progression-free survival (PFS)
時間枠：Baseline to study completion, approximately 5 years
|
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer |
Baseline to study completion, approximately 5 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
1年のランドマークでの陰性生検率
時間枠：1年
|
1年
|
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有害事象のある患者の割合
時間枠：研究薬の最後の投与から30日後
|
研究薬の最後の投与から30日後
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。