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New treatment option for Prostate Cancer
Official title Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT04894188
What this study is testing
What is Goserelin 3.6 MG?
Goserelin 3.6 MG is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for prostate cancer.
Also referred to as ZOLADEX.
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
- RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells.
- 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 20 to 75, men only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Human immunodeficiency virus-positive people with 1 or more of the following:
See the full eligibility 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; people must be willing and able to adhere to...
- 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
- 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...
- Human immunodeficiency virus-positive people 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
- 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...
- Gastrointestinal conditions affecting absorption
The study team makes the final eligibility decision.
Where it's taking place
- Douliu City/Huwei Township, Yunlin County, Taiwan
- Tapiei, Taiwan
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, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Douliu City/Huwei Township, Yunlin County, Taiwan; Tapiei, Taiwan. 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.