PSMA Response in Metastasized Hormone Sensitive Prostate Cancer - Enzalutamide

NCT05539300 | Unknown

• 1 other identifier: NL81959.041.22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• CRPC

  Development of castration-resistant prostate cancer

  12-24 months after start

Secondary Outcomes (1)

• Second line therapy

  12-24 months after start

Study Arms (1)

PSMA response evaluation arm

EXPERIMENTAL

PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy

Diagnostic Test: PSMA-PET/CT response evaluation

Interventions

PSMA-PET/CT response evaluation DIAGNOSTIC_TEST

PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy

PSMA response evaluation arm

Eligibility Criteria

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

You may qualify if:

• Men \>18 years of age.
• Mentally competent and understanding of benefits and potential burden of the study.
• Written and signed informed consent.
• Histological confirmed diagnosis of adenocarcinoma of the prostate.
• Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
• Indicated to start on upfront therapy (enzalutamide).
• Any initial PSA.
• Any Gleason score.
• Any T-stage.
• Any N-stage.
• Stage M1, with multiple / high volume metastasis: More than three (\>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent.

You may not qualify if:

• Concomitant malignancy (except from BCC of the skin).
• History of prior diagnosed or treated PCa.
• Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study.
• Any known allergy for the upfront therapy.
• Any known allergy for LHRH agonist or antagonist.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

Roderick van den Bergh

Utrecht, 3583VS, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roderick CN van den Bergh

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 14, 2022
• Study Start: March 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

NL (1)