Hormone and Radiation Therapy Before Prostate Surgery for High-Risk Cancer

Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Locally Advanced Prostate Cancer and Biomarker Research

This study is testing if giving hormone therapy and radiation before surgery helps men with high-risk prostate cancer do better than just hormone therapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 20 Years to 75 Years
• Sex: Male
• Sponsor: National Taiwan University Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 2 sites (Douliu City/Huwei Township, Yunlin County and 1 other locations)
• Trial ID: NCT04894188 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of combining neoadjuvant hormone therapy and radiation therapy followed by radical prostatectomy in men with high-risk locally advanced prostate cancer. Participants are randomly assigned to receive either both hormone and radiation therapy or hormone therapy alone before undergoing surgery. The primary goal is to assess the success rate of salvage radiation therapy based on pathologic response, while secondary objectives include monitoring PSA levels, surgical outcomes, and overall survival rates over a follow-up period of up to 20 years.

Who should consider this trial

Good fit: Ideal candidates are men aged 20 to 75 with high-risk locally advanced prostate cancer who are willing to undergo surgery.

Not a fit: Patients with metastatic prostate cancer or those who have received prior hormone therapy or radiation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with high-risk prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant approaches, indicating potential for success in this trial.

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

Where this trial is running

Douliu City/Huwei Township, Yunlin County and 1 other locations

• National Taiwan University Hospital Yunlin Branch — Douliu City/Huwei Township, Yunlin County, Taiwan (Recruiting)
• National Taiwan University Hospital — Tapiei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chao-Yuan Huang, MD, PhD — National Taiwan University Hospital
• Study coordinator: Chi-Shin Tseng, MD

Conditions Prostate Cancer