Tutkimus, jossa selvitetään, kuinka hyvin darolutamidin ja androgenisen riistohoidon (ADT) yhdistelmä toimii leikkaushoidon edeltävänä hoidona miehillä, joilla on korkean riskin paikallistunut eturauhassyöpä. (CHINANEO)
CHINANEO: Kiinan vaiheen 2, avoimen, satunnaistetun, monikeskuksellisen tutkimuksen tehokkuuden ja turvallisuuden selvittäminen darolutamidi + ADT:n käytössä 12 viikon vs 24 viikon neoadjuvanttina hoidossa potilaille, joilla on suunniteltu radikaali eturauhasen poisto (RP) korkean riskin paikallisessa eturauhassyövässä
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.
The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g.,testosterone) in the body.
The main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).
The study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.
Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2years after the surgery.
2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.
During the study, the doctors and their study team will:
- take blood and urine samples
- check the participants' health parameters
- do physical examinations
- check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
- take tumor samples
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
About 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Bayer Clinical Trials Contact
- Puhelinnumero: 0018888422937
- Sähköposti: clinical-trials-contact@bayer.com
Opiskelupaikat
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Anhui
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Hefei, Anhui, Kiina, 230601
- Rekrytointi
- The Second Affiliated Hospital of Anhui Medical University
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100034
- Ei vielä rekrytointia
- Peking University First Hospital
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Beijing, Beijing Municipality, Kiina, 100021
- Rekrytointi
- Cancer Hospital, Chinese Academy of Medical Sciences
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Fujian
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Fuzhou, Fujian, Kiina, 350005
- Rekrytointi
- The First Affiliated Hospital of Fujian Medical University
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Gansu
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Lanzhou, Gansu, Kiina, 730030
- Rekrytointi
- The Second Hospital & Clinical Medical School, Lanzhou University
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Guangdong
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Guangzhou, Guangdong, Kiina, 510515
- Rekrytointi
- Nanfang Hospital
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Guangzhou, Guangdong, Kiina, 510120
- Rekrytointi
- The first Affiliated Hospital of Guangzhou Medical University
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Hebei
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Shijiazhuang, Hebei, Kiina, 050000
- Rekrytointi
- The 2nd Hospital of Hebei Medical University
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Heilongjiang
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Harbin, Heilongjiang, Kiina, 150001
- Ei vielä rekrytointia
- The 2nd Affiliated Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, Kiina, 450052
- Ei vielä rekrytointia
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Kiina, 430060
- Rekrytointi
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, Kiina, 430022
- Rekrytointi
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, Kiina, 210008
- Rekrytointi
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
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Jiangxi
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Nanchang, Jiangxi, Kiina, 330006
- Rekrytointi
- The First Affiliated Hospital of Nanchang University
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Liaoning
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Shenyang, Liaoning, Kiina, 110001
- Ei vielä rekrytointia
- The First Hospital of China Medical University
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Shandong
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Jinan, Shandong, Kiina, 250012
- Rekrytointi
- Qilu Hospital of Shandong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 200080
- Rekrytointi
- Shanghai General Hospital
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Shanghai, Shanghai Municipality, Kiina, 200092
- Rekrytointi
- Xinhua Hospital affiliated to shanghai jiao tong university school of medicine
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Sichuan
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Chengdu, Sichuan, Kiina, 610041
- Ei vielä rekrytointia
- Sichuan Cancer Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kiina, 300211
- Ei vielä rekrytointia
- The Second Hospital of Tianjin Medical University
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Yunnan
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Kunming, Yunnan, Kiina, 650101
- Rekrytointi
- The Second Affiliated Hospital of Kunming Medical University
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Zhejiang
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Dongyang, Zhejiang, Kiina, 322100
- Rekrytointi
- Dongyang People's Hospital
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Jinhua, Zhejiang, Kiina, 321000
- Rekrytointi
- Jinhua Municipal Central Hospital (Affiliated Jinhua Hospital, Zhejiang University School of Medicine)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
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Participants must be 18 years or older at the time of signing the informed consent.
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Darolutamide-naïve participants who are with localized prostate adenocarcinoma who plan to receive radical prostatectomy (RP) and defined as high risk with National Comprehensive Cancer Network (NCCN) criteria (version 1.2025).
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No evidence of distant metastasis based on computed tomography (CT), magnetic resonance imaging (MRI), and whole body bone scan (WBBS) within 42 days prior to start of study treatment.
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Candidate for RP with pelvic lymph node dissection (PLND) or extended PLND (ePLND) as per the investigator.
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Participants must have at least one of the following features according to NCCN definition of high-risk:
- Biopsy Gleason score ≥8, and/or
- Prostate-specific antigen (PSA) >20 ng/mL measured during Screening and prior to randomization, or
- Clinical stage ≥ T3a.
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Participants with pelvic lymph node involvement (N1) can be included.
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion Criteria:
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Prostate cancer with known neuroendocrine (NE) differentiation or small cell features.
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Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of the chest, pelvis, and the abdomen (CT or MRI with intravenous [IV] contrast), and WBBS. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
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Intolerant to darolutamide or androgen deprivation therapy (ADT) treatment.
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History of
- Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomization, or
- Significant cardiovascular disease within 6 months prior to randomization.
- Any contraindications for RP.
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Uncontrolled or treatment-resistant hypertension.
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History of another malignancy within 5 years prior to randomization.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Darolutamide + ADT (12 weeks)
Participants will receive darolutamide and androgen deprivation therapy (ADT) as neoadjuvant treatment for 12 weeks, followed by radical prostatectomy (RP). |
Oral tablets of 600 mg twice daily (BID). Goserelin acetate implant (ZOLADEX), at a dose of 10.8 mg, will be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line. |
|
Kokeellinen: Darolutamide + ADT (24 weeks)
Participants will receive darolutamide and androgen deprivation therapy (ADT) as neoadjuvant treatment for 24 weeks, followed by radical prostatectomy (RP). |
Oral tablets of 600 mg twice daily (BID). Goserelin acetate implant (ZOLADEX), at a dose of 10.8 mg, will be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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The proportion of participants achieving pathologic response rate (pRR: pathologic complete response [pCR] or minimal residual disease [MRD])
Aikaikkuna: Completion of Follow-up 1, 30 days after last dose of study drug
|
pRR is defined as the proportion of participants with either condition of pCR or MRD at week 12 or 24 in corresponding arm. Proportion of participants with pCR is defined as the proportion of participants with no residual tumor detected in radical prostatectomy (RP) specimens following 12 or 24 weeks of neoadjuvant treatment of darolutamide and ADT per randomization. Proportion of participants with MRD is defined as the proportion of participants that have residual cancer burden (RCB) ≤0.25 cm^3 in the RP specimens. |
Completion of Follow-up 1, 30 days after last dose of study drug
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of participants with pathologic complete response (pCR)
Aikaikkuna: Completion of Follow-up 1, 30 days after last dose of study drug
|
Proportion of participants with pCR is defined as the proportion of participants with no residual tumor detected in radical prostatectomy (RP) specimens following 12 or 24 weeks of neoadjuvant treatment of darolutamide and ADT per randomization. |
Completion of Follow-up 1, 30 days after last dose of study drug
|
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Percentage of participants with tumor downstaging (e.g. clinical T3 to pathologic T2)
Aikaikkuna: At baseline and immediately after radical prostatectomy
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The pathology review will compare the T stage of tumor tissue at baseline (Screening) with the T stage of radical prostatectomy (RP) specimen at RP and calculate the proportion of participants whose tumor stage has decreased from the baseline T stage. |
At baseline and immediately after radical prostatectomy
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Percentage of participants with positive surgical margin (PSM)
Aikaikkuna: Immediately after radical prostatectomy
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PSM is defined as the presence of cancer cells at the edge of the tissue removed during surgery. |
Immediately after radical prostatectomy
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Biochemical complete response (CR) rate prior to radical prostatectomy (RP) and at landmark timepoints post-RP
Aikaikkuna: At pre-RP, at 5 weeks, 12 weeks post-RP, and every 3 months after that until Year 2 after RP or end of follow up
|
Biochemical CR rate is defined as participants who attain serum prostate-specific antigen (PSA) level below 0.1 ng/mL (PSA <0.1 ng/mL). |
At pre-RP, at 5 weeks, 12 weeks post-RP, and every 3 months after that until Year 2 after RP or end of follow up
|
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Biochemical recurrent free survival since radical prostatectomy (RP) among participants with prostate-specific antigen (PSA) <0.1 ng/mL after RP
Aikaikkuna: From RP to biochemical recurrence or death whichever occurs first, up to 2.5 years
|
Biochemical recurrent free survival is defined as time from RP to biochemical recurrence or death, whichever occurs first. The endpoint will be assessed only among participants with PSA <0.1 ng/mL after RP. Biochemical recurrence is defined as PSA ≥0.1 ng/mL in 2 consecutive measurements after RP. The date of the first measurement defines the date of biochemical recurrence. |
From RP to biochemical recurrence or death whichever occurs first, up to 2.5 years
|
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Incidence and severity of treatment-emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs])
Aikaikkuna: From first dose of study drug up to 30 days after the end of study drug administration
|
TEAEs are defined as AEs with an onset date on or after the first dose of study drug and up to the end-of-study drug plus 30 days or with an onset date prior to the first dose of study drug but worsening in intensity after the study drug. Events with missing onset dates will be included as treatment-emergent. |
From first dose of study drug up to 30 days after the end of study drug administration
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 22982
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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