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

NCT04894188 | Recruiting

• 1 other identifier: 202101088RINA
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic outcome

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

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

Secondary Outcomes (7)

• PSA decline percentage

  From date of randomization to 10 years

• PSA complete response rate

  From date of randomization to 10 years

• PSA Recurrence

  From date of randomization to 10 years

• Distant Failure

  From date of randomization to 10 years

• Prostate Cancer Death

  From date of randomization to 10 years

Study Arms (2)

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

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

Drug: Goserelin 3.6 MG; Procedure: radical prostatectomy

Interventions

radiation therapy RADIATION

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).

Neoadjuvant RT and ADT

Goserelin 3.6 MG DRUG

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

Also known as: ZOLADEX

Neoadjuvant ADT; Neoadjuvant RT and ADT

radical prostatectomy PROCEDURE

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

Neoadjuvant ADT; Neoadjuvant RT and ADT

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• Human immunodeficiency virus-positive subjects 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 malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
• Gastrointestinal conditions affecting absorption

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital Yunlin Branch

Douliu City/Huwei Township, Yunlin County, Taiwan

RECRUITING

National Taiwan University Hospital

Tapiei, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Chao-Yuan Huang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Shin Tseng, MD

CONTACT

+886223123456; clifford1987tcs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 20, 2021
• Study Start: January 27, 2022
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2041
• Last Updated: April 7, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)