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PSMA MRI Guided Prostate SBRT (ARGOS)/Uitgebreide, longitudinale evaluatie van beeldvormende biomarkers na radiotherapie (CLIMBER) (ARGOS/CLIMBER)

30 september 2026 bijgewerkt door: Glenn Bauman, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

PSMA MRI Guided Prostate SBRT(ARGOS)/Uitgebreide, longitudinale evaluatie van beeldvormende biomarkers na radiotherapie (CLIMBER)

This study is a prospective Phase I/II protocol enrolling men with either high intermediate-risk or high-risk or very high-risk prostate cancer. All men will have PSMA Targeted PET (using the PSMA targeting ligand PSMA 1007) and multiparametric magnetic resonance imaging (mpMRI) for delineation of intra-prostatic foci of cancer and any involved regional lymph nodes based on high SUV uptake on PET or mpMRI (T2W, DWI/ADC, DCE) appearance suspicious for cancer. Tumour delineation will be performed by fusing the PSMA PET and mpMRI with planning CT simulation images. Fiducial marker implantation for treatment guidance will be mandatory but use of other organs at risk protection strategies (i.e. GU Loc, Space-OAR) will be allowed but not mandatory. Patients will be treated with image-guided SBRT using the fiducial markers for intra-fraction motion management. Dose escalation to imaging defined targets (intra-prostatic and involved nodes on PSMA PET + MRI) will be accomplished through a simultaneous boost technique. Maintaining dose to organs at risk will take precedence over boost dose targets (targeted maximum dose of 50Gy/5 fractions to imaging defined prostatic lesion; 35Gy/5 fractions to imaging defined involved nodes).

Cohort extension: We hypothesize that integration of neoadjuvant androgen deprivation therapy will provide for pretreatment cancer downstaging and will allow us to achieve higher target doses to the imaging defined DILs than currently achieve. Additionally, we plan to include a novel sodium MRI protocol into the baseline imaging to compare DIL volumes delineated by this modality to those by mpMRI and PSMA PET and to characterize changes in sodium MRI in response to ADT alone and subsequent radiotherapy

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Research Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • Age > 18 years of age
  • Histologically confirmed carcinoma of the prostate
  • High-intermediate risk or high risk as defined by NCCN criteria:
  • High intermediate: 2 or 4 intermediate risk factors (T2B-T2C, Gleason GG 2 or 3, PSA 10-20) or GG 3 or intermediate risk with equal or >50% biopsy core involvement
  • High-risk: one of T3a, Gleason GG 4 or 5, or PSA >20 ng/ml
  • Very-high risk: one of primary Gleason Pattern 5, >4 cores Grade Group 4 or 5, clinical T3b, or more than 1 high-risk feature
  • Conventional imaging (bone scan and abdominal pelvic computed tomography) negative for extra-pelvic nodal, skeletal or visceral metastases
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete EPIC questionnaires

Exclusion Criteria:

  • Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
  • Men with clinical T4 disease are excluded
  • Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.)
  • Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Poor baseline urinary function defined as a score of 5 ("big problem") on question 5 of the EPIC 26 (Overall, how big a problem has your urinary function been for you during the last 4 weeks?)
  • Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Men with high intermediate to very high risk prostate cancer

Men with high intermediate to very high risk prostate cancer
Straling: High-Intermediate Risk Patients-cohort 1

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Six months of androgen deprivation therapy will commence with the end of radiotherapy (concurrent plus adjuvant)

Straling: High Risk or Very High-Risk Patients-cohort 1

Patients will receive 35Gy/5 fractions to the whole prostate (25Gy to whole Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Pelvic lymph nodes will receive 25Gy/5 fractions synchronous with prostate treatment with a simultaneous boost to imaging involved nodes to a maximum of 35Gy/5 fractions. Eighteen months of androgen deprivation therapy will commence with the end of radiotherapy (concurrent plus adjuvant)

Straling: High-Intermediate Risk Patients-cohort 2

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Androgen deprivation therapy will commence 3 months before radiotherapy (concurrent plus adjuvant) and will continue for a total of 6 months.

Straling: High Risk or Very High-Risk Patients-cohort 2

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Androgen deprivation therapy will commence 3 months before radiotherapy (concurrent plus adjuvant) and will continue for a total of 18 months.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-month Toxicity
Tijdsspanne: 6-months

6-month gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
6-months
6-week Toxicity
Tijdsspanne: 6-weeks

6-week gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
6-weeks
Expansion cohort: Median minimum dose to dominant intra-prostatic lesion
Tijdsspanne: 6-months

Expansion cohort: Median minimum dose to dominant intra-prostatic lesion
6-months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of Life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires
Tijdsspanne: 5 years

Quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires.
5 years
Disease Free Survival
Tijdsspanne: 5 years

Five-year disease-free survival (DFS) as a composite of biochemical control, patient death or development of clinical metastases or institution of salvage ADT.
5 years

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Translational Endpoint 1
Tijdsspanne: 24 months

Serial PSMA PET/MRI images will be collected at baseline, 6 months and 2 years to characterize the imaging response of prostate cancer to treatment and potentially identify imaging biomarkers (including pharmacokinetic, radiomic and quantitative PET and mpMRI metrics) that predict for five-year DFS
24 months
Translational Endpoint 2
Tijdsspanne: 24 Months

Baseline collection of diagnostic tissue biopsy samples and serial collection of blood and urine over multiple time points (baseline, 6 months, 1 year, 2 years post radiotherapy) for correlative biologic biomarker analyses with imaging changes and disease-free survival and toxicity post treatment
24 Months
Translational Endpoint 3
Tijdsspanne: 2 years

A prostate biopsy at baseline and 2 years will allow for correlation of histopathology with PSMA PET/MRI images. Specifically, we will investigate biopsy correlations with pre-treatment PSMA PET/MRI images and whether a negative PSMA PET/MRI is correlated with a negative 2-year post treatment biopsy (shown to correlate with long term disease control
2 years
Translational Endpoint 4
Tijdsspanne: 5 years

Examine novel clinical prognostic biomarkers (i.e. percentage of Gleason Pattern 4 on biopsy, 4- year PSA response rate) and their correlation with imaging findings and 5-year Disease Free Survival
5 years
Translational Endpoint- Expansion cohort
Tijdsspanne: 6 months

Characterize intra-prostatic foci on pre, post 3-month ADT and 6 months post radiotherapy on PSMA PET/MRI + sodium MRI imaging
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 mei 2022

Primaire voltooiing (Geschat)

15 december 2028

Studie voltooiing (Geschat)

15 december 2028

Studieregistratiedata

Eerst ingediend

12 januari 2022

Eerst ingediend dat voldeed aan de QC-criteria

25 februari 2022

Eerst geplaatst (Werkelijk)

8 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ARGOS/CLIMBER

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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