NCT04894188 Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer
| NCT ID | NCT04894188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2022-01-27 |
| Primary Completion | 2024-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2022-01-27 with a primary completion date of 2024-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Pathological finding of small cell, ductal or neuroendocrine carcinoma * Current or prior hormone therapy, radiotherapy, or chemotherapy * Evidence of metastasis (M1) on images * Other prior malignancy ≤5 years prior to enrollment * 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 * Human immunodeficiency virus-positive subjects with 1 or more of the following: 1. Not receiving highly active antiretroviral therapy 2. Had a change in antiretroviral therapy within 6 months of the start of screening 3. Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment) 4. CD4 count \<350 at screening 5. AIDS-defining opportunistic infection within 6 months of start of screening * Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction * 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) * Gastrointestinal conditions affecting absorption
Contact & Investigator
Chao-Yuan Huang, MD, PhD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT04894188 clinical trial?
This trial is open to male participants only, aged 20 Years or older, up to 75 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04894188 currently recruiting?
Yes, NCT04894188 is actively recruiting participants. Contact the research team at clifford1987tcs@gmail.com for enrollment information.
Where is the NCT04894188 trial being conducted?
This trial is being conducted at Douliu City/Huwei Township, Taiwan, Tapiei, Taiwan.
Who is sponsoring the NCT04894188 clinical trial?
NCT04894188 is sponsored by National Taiwan University Hospital. The principal investigator is Chao-Yuan Huang, MD, PhD at National Taiwan University Hospital. The trial plans to enroll 38 participants.
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