PSMA Response in Metastasized Hormone Sensitive Prostate Cancer
PET-MaN
Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging
1 other identifier
interventional
150
1 country
4
Brief Summary
PSMA-PET/CT response measurements after LHRH agonist and upfront therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Oct 2021
Typical duration for not_applicable prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2021
CompletedFirst Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
December 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2025
CompletedJanuary 9, 2024
January 1, 2024
4 years
December 3, 2021
January 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CRPC
Development of castration-resistant prostate cancer
18-24 mo after inclusion
Secondary Outcomes (1)
2nd line therapy
18-24 mo after inclusion
Study Arms (1)
PSMA response evaluation arm
EXPERIMENTALPSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront therapy
Interventions
Eligibility Criteria
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 (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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Meander MC
Amersfoort, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
St Antonius Ziekenhuis
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marnix Lam, MD PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. Roderick CN van den Bergh
Study Record Dates
First Submitted
December 3, 2021
First Posted
December 17, 2021
Study Start
October 19, 2021
Primary Completion
October 19, 2025
Study Completion
October 19, 2025
Last Updated
January 9, 2024
Record last verified: 2024-01