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PSMA Response in Metastasized Hormone Sensitive Prostate Cancer (PET-MaN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05161728
Recruitment Status : Recruiting
First Posted : December 17, 2021
Last Update Posted : January 9, 2024
Sponsor:
Information provided by (Responsible Party):
Roderick van den Bergh, UMC Utrecht

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: PSMA-PET/CT Not Applicable

Detailed Description:

Rationale: Men, newly diagnosed with metastasized prostate cancer on PSMA PET/CT, who start on standard hormonal therapy, are additionally treated with either upfront chemotherapy or upfront extra androgen-receptor targeted agents ('ARTA'), as per guidelines' recommendations. The benefit in overall survival of these two options is similar, but important differences exist in patient-specific efficacy, costs, side-effects, and impact on quality of life. No predictive factors are available to individualize treatment choice. Currently, a one-size-fits-all strategy with hormonal therapy plus chemotherapy is usually followed.

Objective: To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.

Study design: Prospective, single arm, open label, non-interventional, non-therapeutic observational cohort study.

Study population: Patients >18 years with newly diagnosed, histologically proven prostate cancer with >3 skeletal or visceral metastatic lesions on the PSMA-PET/CT, who are considered eligible for upfront therapy (apalutamide or abiraterone) in addition to standard hormonal therapy.

Main study parameters/endpoints:

Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront therapy, according to PERCIST criteria. Primary endpoint: Time to development of CRPC. Secondary parameters: Predictive value of early response on PSMA-PET/CT to hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of response in different subgroups of patients: e.g. high versus low tumour load, high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to initiation of second line therapy after castration-resistant disease has been found.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:

Patients will be treated according to standard of care, including baseline PSMA-PET/CT. The timing of follow-up PSMA-PET/CT imaging will be standardized. Instead of imaging at biochemical or clinical signs of disease progression, one PSMA-PET/CT will be performed after two months of hormonal therapy, one PSMA-PET/CT will be performed after two months of upfront therapy. Each PSMA-PET/CT scan will require an extra visit (2-3 hours) and a limited radiation burden after intravenous injection of PSMA. The additional information from the standardized follow-up PSMA-PET/CT scans will not be used for clinical decision-making.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : October 19, 2025
Estimated Study Completion Date : October 19, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: PSMA response evaluation arm
PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront therapy
 Diagnostic Test: PSMA-PET/CT
PSMA-PET/CT


Outcome Measures
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Primary Outcome Measures :
  1. CRPC [ Time Frame: 18-24 mo after inclusion ]
    Development of castration-resistant prostate cancer


Secondary Outcome Measures :
  1. 2nd line therapy [ Time Frame: 18-24 mo after inclusion ]
    Initiation of second line therapy for CRPC


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (apalutamide or abiraterone).
  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05161728


Contacts
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Contact: Roderick van den Bergh, MD PhD +31623456800 roodvdb@hotmail.com

Locations
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Netherlands
Meander MC Recruiting
Amersfoort, Netherlands
Contact: Tom Arends       TJH.Arends@meandermc.nl   
Canisius-Wilhelmina Ziekenhuis Recruiting
Nijmegen, Netherlands
Contact: Jean-Paul van Basten, MD PhD       jpvanbasten@upcmail.nl   
St Antonius Ziekenhuis Recruiting
Utrecht, Netherlands
Contact: Roderick van den Bergh    +31623456800    r.van.den.bergh@antoniusziekenhuis.nl   
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Peter-Paul Willemse       ppmwillemse@hotmail.com   
Sponsors and Collaborators
Roderick van den Bergh
Investigators
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Study Chair: Marnix Lam, MD PhD UMC Utrecht
  Study Documents (Full-Text)

Documents provided by Roderick van den Bergh, UMC Utrecht:
Study Protocol and Statistical Analysis Plan  [PDF] August 18, 2021

More Information
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Responsible Party: Roderick van den Bergh, Dr. Roderick CN van den Bergh, UMC Utrecht
ClinicalTrials.gov Identifier: NCT05161728    
Other Study ID Numbers: NL77093.041.21
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: January 9, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roderick van den Bergh, UMC Utrecht:
psma
response
metastasis
upfront
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Neoplastic Processes
Pathologic Processes