Prostate CancerNCT04894188
Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer
A study testing radiation therapy, Goserelin 3.6 MG and radical prostatectomy in people with Prostate Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- radiation therapy, Goserelin 3.6 MG and radical prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesTaiwan
- Study dates
- 27 Jan 2022to 1 Jul 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- PSA ≥20 ng/ml
- Willing to undergo prostatectomy as primary treatment
- ECOG Performance status 0 or 1
Who cannot join
- 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:
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- 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 malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- Gastrointestinal conditions affecting absorption
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital Yunlin Branch
Douliu City/Huwei Township, Yunlin County
Shi-Wei Huang, PhD, Will6438.huang@gmail.com
- Recruiting
National Taiwan University Hospital
Tapiei
Chi-Shin Tseng, MD, clifford1987tcs@gmail.com
Chao-Yuan Huang, MD, PhD
About this study
Official title: 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
Read the detailed description
PRIMARY OBJECTIVE:
- Success rate of salvage radiation therapy (SRT) measured as pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate.
SECONDARY OBJECTIVES:
- PSA decline rate after neoadjuvant treatment, rate of undetectable PSA after RP, rate of positive surgical margin, and rate of pathologic down-staging (≤ ypT2N0) II. Biochemical recurrence-free survival rate (from date of randomization). III. Metastasis free survival. IV. Prostate Cancer Death. V. Overall Survival
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive neoadjuvant hormone and radiation therapy, and then radical prostatectomy
ARM II: Participants receive neoadjuvant hormone therapy, and then radical prostatectomy.
After intervention, participants are followed up periodically for up to 20 years.
- Conditions
- Prostate Cancer
- Being tested
- radiation therapy, Goserelin 3.6 MG, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Intensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5).
Goserelin 3.6 MGDrug
Also called ZOLADEX
Gosereline 3.6mg sc injection at week 1, week 5, and week 9
radical prostatectomyProcedure or surgery
Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant RT and ADT | Experimental | Intensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5).
Gosereline 3.6mg sc injection at week 1, week 5, and week 9 Receives: Radiation: radiation therapy; Drug: Goserelin 3.6 MG; Procedure: radical prostatectomy |
| Neoadjuvant ADT | Active comparator | Gosereline 3.6mg sc injection at week 1, week 5, and week 9 Receives: Drug: Goserelin 3.6 MG; Procedure: radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic outcome
pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate
Measured: From date of randomization to the date of radical prostatectomy, up to 100 weeks
Secondary outcomes (7)
PSA decline percentage
PSA decline is defined as nadir PSA value/baseline PSA value × 100
Measured: From date of randomization to 10 years
PSA complete response rate
Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml.
Measured: From date of randomization to 10 years
PSA Recurrence
Biochemical recurrence is defined as a rise in PSA to 0.2 ng/mL and a confirmatory value of 0.2 ng/mL or greater following radical prostatectomy
Measured: From date of randomization to 10 years
Distant Failure
Distant failure rate is estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure.
Measured: From date of randomization to 10 years
Prostate Cancer Death
Prostate cancer death rate us estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of trial.
Measured: From date of randomization to 10 years
Overall Survival
Overall survival is estimated by the Kaplan-Meier method, with failure defined as death by any cause.
Measured: From date of randomization to 10 years
Progression-free Survival
Progress-free survival is estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause.
Measured: From date of randomization to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start27 Jan 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao-Yuan Huang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894188
- Sponsor's protocol ID
- 202101088RINA
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Locally Advanced Prostate Cancer and Biomarker Research
- ClinicalTrials.gov ID
- NCT04894188
- Acronym / sponsor ID
- 202101088RINA
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2041 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVE:
- Success rate of salvage radiation therapy (SRT) measured as pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate.
SECONDARY OBJECTIVES:
- PSA decline rate after neoadjuvant treatment, rate of undetectable PSA after RP, rate of positive surgical margin, and rate of pathologic down-staging (≤ ypT2N0) II. Biochemical recurrence-free survival rate (from date of randomization). III. Metastasis free survival. IV. Prostate Cancer Death. V. Overall Survival
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive neoadjuvant hormone and radiation therapy, and then radical prostatectomy
ARM II: Participants receive neoadjuvant hormone therapy, and then radical prostatectomy.
After intervention, participants are followed up periodically for up to 20 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant RT and ADT | Experimental | Radiation: radiation therapy, Drug: Goserelin 3.6 MG, Procedure: radical prostatectomyIntensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5). Gosereline 3.6mg sc injection at week 1, week 5, and week 9 |
| Neoadjuvant ADT | Active comparator | Drug: Goserelin 3.6 MG, Procedure: radical prostatectomyGosereline 3.6mg sc injection at week 1, week 5, and week 9 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Willing to undergo prostatectomy as primary treatment
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapyIntensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5). | Radiation | Neoadjuvant RT and ADT |
| Goserelin 3.6 MGAlso: ZOLADEXGosereline 3.6mg sc injection at week 1, week 5, and week 9 | Drug | Neoadjuvant ADT, Neoadjuvant RT and ADT |
| radical prostatectomyEligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection | Procedure or surgery | Neoadjuvant ADT, Neoadjuvant RT and ADT |
Primary outcome
Pathologic outcome
Time frame: From date of randomization to the date of radical prostatectomy, up to 100 weeks
pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate
7 secondary outcomes
PSA decline percentage
Time frame: From date of randomization to 10 years
PSA complete response rate
Time frame: From date of randomization to 10 years
PSA Recurrence
Time frame: From date of randomization to 10 years
Distant Failure
Time frame: From date of randomization to 10 years
Prostate Cancer Death
Time frame: From date of randomization to 10 years
Overall Survival
Time frame: From date of randomization to 10 years
Progression-free Survival
Time frame: From date of randomization to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao-Yuan Huang, MD, PhD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation therapy, Goserelin 3.6 MG and radical prostatectomy in people with Prostate Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Shin Tseng, MD (+886223123456, clifford1987tcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic outcome (time frame: From date of randomization to the date of radical prostatectomy, up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.