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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

Tracking Information
First Submitted Date  ICMJE December 3, 2021
First Posted Date  ICMJE December 17, 2021
Last Update Posted Date January 9, 2024
Actual Study Start Date  ICMJE October 19, 2021
Estimated Primary Completion Date October 19, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2021)		 CRPC [ Time Frame: 18-24 mo after inclusion ]
Development of castration-resistant prostate cancer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2021)		 2nd line therapy [ Time Frame: 18-24 mo after inclusion ]
Initiation of second line therapy for CRPC
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PSMA Response in Metastasized Hormone Sensitive Prostate Cancer
Official Title  ICMJE Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging
Brief Summary PSMA-PET/CT response measurements after LHRH agonist and upfront therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Diagnostic Test: PSMA-PET/CT
PSMA-PET/CT
Study Arms  ICMJE Experimental: PSMA response evaluation arm
PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront therapy
Intervention: Diagnostic Test: PSMA-PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2021)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 19, 2025
Estimated Primary Completion Date October 19, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roderick van den Bergh, MD PhD +31623456800 roodvdb@hotmail.com
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05161728
Other Study ID Numbers  ICMJE NL77093.041.21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Roderick van den Bergh, UMC Utrecht
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Roderick van den Bergh
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marnix Lam, MD PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP