imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration Resistant ProstaTe Cancer by NGS

NCT04746300 | Unknown

• 2 other identifiers: MOURO41 - PROMPTNL68315.091.19
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer (mCRPC) patients for personalized treatment (e.g. immuno-, PARP inhibitors, or platinum-therapy). The investigators hypothesize that, by doing this early in the disease course (before exhausting standard of care options), it will improve treatment planning, patient outcome, quality of life, and reduce costs.

Conditions

Metastatic Prostate Cancer

Keywords

mCRPC

Outcome Measures

Primary Outcomes (1)

• Responsiveness ratio

  Ratio of radiographic progression-free survival of personalized treatment or standard of care to the standard last line therapy (PFS-MPT-ratio vs PFS-SOC-ratio)

  Throughout completion of study (estimated 5 years from start)

Secondary Outcomes (12)

• Efficacy endpoint: ORR

  Throughout completion of study (estimated 5 years from start)

• Efficacy endpoint: rPFS

  Throughout completion of study (estimated 5 years from start)

• Efficacy endpoint: PSA response

  Throughout completion of study (estimated 5 years from start)

• Efficacy endpoint: PSA-PFS

  Throughout completion of study (estimated 5 years from start)

• Efficacy endpoint: OS

  Throughout completion of study (estimated 5 years from start)

Study Arms (3)

Group 1: no sequencing

Participants in this group, for which DNA sequencing could not be reported due to a variety of (quality/technical) reasons, will be treated with standard of care therapy. This group is therefore comparable to patients treated outside the Radboudumc.

Procedure: Biopsy; Procedure: Blood sample

Group 2: no druggable aberration

Participants in this group received a DNA sequencing report identifying no biomarkers to which a logical treatment option can be connected. These participants will also receive standard of care therapy.

Procedure: Biopsy; Procedure: Blood sample

Group 3: allocated to personalized treatment

Participants in this group received a DNA sequencing report which identified presence of a biomarker allowing the participant to be treated with a personalized therapy. This therapy could range from immunotherapy, or PARP inhibitors, to other medication.

Procedure: Biopsy; Procedure: Blood sample

Interventions

Biopsy PROCEDURE

A biopsy will be taken from metastatic tissue, which will be used for DNA sequencing

Group 1: no sequencing; Group 2: no druggable aberration; Group 3: allocated to personalized treatment

Blood sample PROCEDURE

Blood samples will be taken for additional translational research

Group 1: no sequencing; Group 2: no druggable aberration; Group 3: allocated to personalized treatment

Eligibility Criteria

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

Study Population

A total of 600 patients with metastatic castration-resistant prostate cancer with clinical, radiographic or biochemical disease progression may be included in this study. The expected number of patients eligible for the protocol is well above 200 patients per year, including referrals from regional/community hospitals.

You may qualify if:

• Male aged 18 or older with adenocarcinoma of the prostate defined by: Documented histopathology at diagnosis of prostate adenocarcinoma without evidence of predominant or primary neuroendocrine histology.
• Patients with a metastatic tumor site accessible for image-guided biopsy and allowing research analyses for this trial (e.g. biomarker testing by genomic, proteomic or transcriptomic assessment). A waiver can be made for patients presenting with metastatic hormone-sensitive prostate cancer (mHSPC), and no easily accessible tumour for biopsy and suitable primary tissue available for NGS.
• Castration-resistant state (defined as disease progressing despite \[chemical\] castration per PCWG3 criteria)
• Progressive disease as either
• A rising PSA on minimum 2 serial consecutive measurements
• Radiographic soft tissue progression per RECIST1.1 or bone progression per PCWG3 criteria
• Clinical progression
• At least one metastatic lesion present at baseline CT, MRI, 68Ga/18F-PSMA PET or bone scan
• ECOG Performance status 0 to 2
• Serum testosterone on castration level
• Adequate renal function:
• MDRD-GFR ≥ 30 ml/min/1.73m2
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x109/L

You may not qualify if:

• Prior chemotherapy and androgen receptor inhibition therapy related to castration resistant prostate cancer (one line of chemotherapy or androgen receptor inhibition may be given in the hormone-sensitive setting)
• Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer. A waiver may be obtained from the PI in cases where the active malignancy is indolent and believed not to reduce mortality.
• Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI).
• Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
• Any condition which, in the opinion of the investigator, would preclude participation in this observational study.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• VGZ health insurance (NL): collaborator
• Paul Speth Foundation (NL): collaborator
• Radboud Oncology Fund (NL): collaborator

Study Sites (1)

Radboud UMC

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

CT-guided biopsies from lymph node, soft tissue, viscera and bone are collected. Blood and urine specimens are collected.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; Blood Specimen Collection

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)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Punctures

Central Study Contacts

Niven Mehra, MD, PhD

CONTACT

+312410354; niven.mehra@radboudumc.nl

Iris Kloots, MD

CONTACT

iris.kloots@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 9, 2021
• Study Start: February 4, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 9, 2021

Record last verified: 2021-01

Locations

NL (1)