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NCT Number: NCT07560748

Prospective Prostate Cancer Infrastructure

The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.

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Key information

Conditions

High Risk Localized Prostate Cancer Synchronous Metastatic Hormone-Sensitive Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA > 20 ng/mL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET/CT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.
  • Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate
  • Age ≥ 18 years at the time of inclusion.
  • Written informed consent
  • Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.

Exclusion criteria

  • Not currently living in the Netherlands.

Treatment and study plan

Primary outcomes

  1. Treatment patterns

    Time frame: From diagnosis through study completion, up to 4 years

    Documentation of initial and sequential treatment strategies, including type, timing, and combination of androgen deprivation therapy, androgen receptor pathway inhibitors, chemotherapy, and radiotherapy, within 4 months and beyond 4 months after diagnosis.

  2. PSA response

    Time frame: From treatment initiation up to 12 months.

    Proportion of patients achieving >50% and >90% PSA decline from baseline within the first year after treatment initiation.

  3. PSA nadir

    Time frame: From treatment initiation up to 12 months

    Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.

  4. Utilization of imaging modalities for primary staging

    Time frame: At baseline

    Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI.

  5. Time to clinical progression

    Time frame: From treatment initiation through study completion, up to 4 years

    Time from treatment initiation to clinical progression, defined as local progression, and/or symptomatic skeletal events (pain, fracture, spinal cord compression), or initiation of surgery or radiotherapy for progression.

  6. Time to biochemical progression

    Time frame: From treatment initiation through study completion, up to 4 years

    Time from treatment initiation to biochemical progression per PCWG3 criteria, defined as a minimum PSA rise of 25% AND an absolute increase of 2ng/mL from the nadir, confirmed on two measurements ≥3 weeks apart.

  7. Time to radiographic progression

    Time frame: From treatment initiation through study completion, up to 4 years

    Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria.

  8. Time to castration-resistant prostate cancer (CRPC)

    Time frame: From treatment initiation through study completion, up to 4 years

    Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.

  9. Overall survival

    Time frame: From diagnosis through study completion, up to 4 years

    Time from diagnosis to death from any cause.

  10. Adverse events

    Time frame: From treatment initiation through study completion, up to 4 years

    Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0.

  11. Number of hospital admissions

    Time frame: From treatment initiation through study completion, up to 4 years

    Total number of planned and unplanned hospital admissions.

  12. Number of outpatient visits

    Time frame: From treatment initiation through study completion, up to 4 years

    Total number of outpatient visits

Secondary outcomes

  1. Dynamic change in ctDNA fraction

    Time frame: Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.

    Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.

  2. Prevalence and clinical phenotypes of genomic alterations

    Time frame: At diagnosis or at disease progression, up to 4 years

    Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue.

  3. Health-Related Quality of Life (Global Health Status)

    Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

    Clinically meaningful change in Global Health Status using the EORTC QLQ-C30 as a measure for Health Related Quality of Life, from baseline to sequential follow-up.

  4. Health-Related Quality of Life (Health Utility)

    Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months

    Change in health utility index and EQ Visual Analogue Scale score measured using the EQ-5D-5L, across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  5. Pain intensity and interference

    Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

    Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).

  6. Fatigue severity and interference

    Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

    Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).

  7. Prostate cancer-specific symptoms

    Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

    Change in prostate cancer-specific symptoms measured using the EORTC QLQ-PR25, domain scores for urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: ProPCI

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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