Tests radiation and hormone therapy before surgery for high-risk prostate cancer
Tests radiation and hormone drug before prostate removal in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer
Key facts
- Where
- Douliu City/Huwei Township and Tapiei, TaiwanSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 75 years old?
Source: NCT04894188, who can take part
Where in Taiwan
- National Taiwan University Hospital Yunlin BranchDouliu City/Huwei Township, TaiwanTaking people
- National Taiwan University HospitalTapiei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT04894188
- Record updated
- 7 April 2022
- Original description
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy can fight prostate cancer by androgen deprivation. It is not yet known if neoadjuvant radiation therapy is a more effective therapy for high-risk prostate cancer.Read full original descriptionShow less
Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Locally Advanced Prostate Cancer and Biomarker Research
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy can fight prostate cancer by androgen deprivation. It is not yet known if neoadjuvant radiation therapy is a more effective therapy for high-risk prostate cancer.
PURPOSE: Two-stage randomized trial to compare the effectiveness and safety of neoadjuvant radiotherapy and hormone therapy followed by radical prostatectomy in men with high-risk locally advanced prostate cancer
Inclusion: Men with age from 20 to 75 years old; Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol; Histologically confirmed adenocarcinoma of the prostate; High-risk locally advanced disease defined by ≥1 of the following 3 criteria:; T3a-3b by DRE or MRI; Gleason score ≥ 8 (= Grade group 4); PSA ≥20 ng/ml; Willing to undergo prostatectomy as primary treatment; ECOG Performance status 0 or 1.
Exclusion: Current or prior hormone therapy, radiotherapy, or chemotherapy; Any of the following within 6 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary; History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect); Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction; Gastrointestinal conditions affecting absorption; Human immunodeficiency virus-positive subjects with 1 or more of the following:; Not receiving highly active antiretroviral therapy; Had a change in antiretroviral therapy within 6 months of the start of screening; Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment); CD4 count <350 at screening; AIDS-defining opportunistic infection within 6 months of start of screening; Other prior malignancy ≤5 years prior to enrollment; Pathological finding of small cell, ductal or neuroendocrine carcinoma; Evidence of metastasis (M1) on images.