AzTrials
AzTrials

Prostate CancerARGOS/CLIMBERNCT05269550

PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)

A study testing High-Intermediate Risk Patients-cohort 1, High Risk or Very High-Risk Patients-cohort 1 and High-Intermediate Risk Patients-cohort 2 in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
High-Intermediate Risk Patients-cohort 1, High Risk or Very High-Risk Patients-cohort 1 and High-Intermediate Risk Patients-cohort 2
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesCanada
Study dates
3 May 2022to 15 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

Official title: PSMA MRI Guided Prostate SBRT(ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (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

Conditions
Prostate Cancer
Being tested
High-Intermediate Risk Patients-cohort 1, High Risk or Very High-Risk Patients-cohort 1, High-Intermediate Risk Patients-cohort 2, High Risk or Very High-Risk Patients-cohort 2
Keywords
High intermediate risk prostate cancer, High-risk prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Intermediate Risk Patients-cohort 1Radiation

    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)

  • High Risk or Very High-Risk Patients-cohort 1Radiation

    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)

  • High-Intermediate Risk Patients-cohort 2Radiation

    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.

  • High Risk or Very High-Risk Patients-cohort 2Radiation

    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.

Study groups in NCT05269550
Study groupRoleWhat they receive
Men with high intermediate to very high risk prostate cancerExperimentalMen with high intermediate to very high risk prostate cancer
Receives: Radiation: High-Intermediate Risk Patients-cohort 1; Radiation: High Risk or Very High-Risk Patients-cohort 1; Radiation: High-Intermediate Risk Patients-cohort 2; Radiation: High Risk or Very High-Risk Patients-cohort 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month Toxicity

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

    Measured: 6-months

  2. 6-week Toxicity

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

    Measured: 6-weeks

  3. Expansion cohort: Median minimum dose to dominant intra-prostatic lesion

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

    Measured: 6-months

Secondary outcomes (2)

  1. Quality of Life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires

    Quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires.

    Measured: 5 years

  2. Disease Free Survival

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start3 May 2022
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269550
Sponsor's protocol ID
ARGOS/CLIMBER
Acronym
ARGOS/CLIMBER
Status last verified
Sep 2026
First submitted
12 Jan 2022
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-Intermediate Risk Patients-cohort 1, High Risk or Very High-Risk Patients-cohort 1 and High-Intermediate Risk Patients-cohort 2 in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month Toxicity (time frame: 6-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05269550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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