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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

radiation therapy

Goserelin 3.6 MG

radical prostatectomy

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

National Taiwan University Hospital Yunlin BranchRecruiting
National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant RT and ADT

Neoadjuvant ADT

Arm Description

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

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

Outcomes

Primary Outcome Measures

Pathologic outcome

pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate

Secondary Outcome Measures

PSA decline percentage

PSA decline is defined as nadir PSA value/baseline PSA value × 100

PSA complete response rate

Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml.

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

Distant Failure

Distant failure rate is estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure.

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.

Overall Survival

Overall survival is estimated by the Kaplan-Meier method, with failure defined as death by any cause.

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.

Full Information

NCT ID

NCT04894188

First Posted

May 9, 2021

Last Updated

April 5, 2022

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04894188

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 27, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2041 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed Description

PRIMARY OBJECTIVE: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant RT and ADT

Arm Type

Experimental

Arm Description

Arm Title

Neoadjuvant ADT

Arm Type

Active Comparator

Arm Description

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Goserelin 3.6 MG

Other Intervention Name(s)

ZOLADEX

Intervention Description

Gosereline 3.6mg sc injection at week 1, week 5, and week 9

Intervention Type

Procedure

Intervention Name(s)

radical prostatectomy

Intervention Description

Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection

Primary Outcome Measure Information:

Title

Pathologic outcome

Description

pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate

Time Frame

From date of randomization to the date of radical prostatectomy, up to 100 weeks

Secondary Outcome Measure Information:

Title

PSA decline percentage

Description

PSA decline is defined as nadir PSA value/baseline PSA value × 100

Time Frame