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New treatment option for Neoadjuvant Therapy
Official title Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT05406999
What this study is testing
What is ADT?
ADT is an investigational medicine, being studied as a potential treatment for neoadjuvant therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
- All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging...
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
- Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of...
You likely can't join if
- Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
- Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a)...
- Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not...
- Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate...
- Patients with severe or uncontrolled concurrent infections are not eligible.
- Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any...
See the full eligibility criteria
- All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
- All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8...
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
- Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must bewilling...
- Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.
- Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
- Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor \<...
- Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.
- Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.
- Patients with severe or uncontrolled concurrent infections are not eligible.
- Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction...
- Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
- Patients with mental illness, mental disability or inability to give informed consent are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.