MRI-Guided Prostate SBRT for Prostate Cancer

(ARGOS/CLIMBER Trial)

Not currently recruiting at 1 trial location

Overseen By Lucas Mendez, MD

Age: 18+

Sex: Male

Trial Phase: Academic

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

Must not be taking: Anticoagulants

Disqualifiers: T4 disease, Connective tissue disease, Inflammatory bowel disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 fractions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating prostate cancer using MRI-guided radiation therapy, known as PSMA MRI Guided Prostate SBRT. The goal is to determine if this approach can more precisely target cancer cells in men with high to very high-risk prostate cancer. The study also examines whether adding hormone therapy before treatment helps shrink the cancer and permits higher radiation doses. Men with prostate cancer that has not spread outside the pelvis and who have not undergone major prostate treatments might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could enhance future prostate cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on androgen deprivation therapy or if it's unsafe to stop anticoagulation medication for a procedure.

What prior data suggests that this MRI-guided prostate SBRT is safe for prostate cancer treatment?

Research has shown that PSMA MRI-guided prostate SBRT, a type of targeted radiation therapy, is generally well-tolerated by patients. This method uses advanced imaging to accurately target prostate cancer, making it a safe option for treating high-risk cases. For instance, combining PET scans with MRI helps pinpoint cancer areas, allowing precise treatment while protecting healthy tissue.

In previous studies, most side effects were mild and temporary, such as tiredness or urinary problems, while serious side effects were rare. Although these results are promising, individual experiences can vary. Anyone considering joining a clinical trial should discuss the potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PSMA MRI Guided Prostate SBRT because it offers a novel approach to treating prostate cancer by using advanced imaging technology to enhance precision. Unlike traditional radiation therapies, which can affect surrounding healthy tissue, this technique leverages MRI guidance to target tumors with exceptional accuracy. This precision minimizes damage to healthy tissue, potentially reducing side effects for patients. Additionally, the use of PSMA imaging allows for better visualization of prostate cancer cells, which could lead to more effective treatments and improved outcomes.

What evidence suggests that this MRI-guided prostate SBRT is effective for prostate cancer?

Research has shown that PSMA MRI Guided Prostate SBRT, a precise radiation therapy, offers a promising treatment for high-risk prostate cancer. In this trial, participants will receive PSMA MRI Guided Prostate SBRT. Studies have found that [18F]PSMA-1007 PET/CT scans effectively identify and target prostate cancer spots, enhancing the precision of radiation therapy. This method is highly sensitive, excelling at detecting cancerous areas. When combined with multiparametric MRI, PSMA PET further enhances the ability to locate and treat specific cancer tissues. Overall, these imaging techniques enable more accurate targeting of cancer, potentially leading to better treatment outcomes. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Men over 18 with high intermediate-risk, high-risk, or very high-risk prostate cancer that hasn't spread beyond the pelvis. They must have no history of prior prostate cancer treatments (except for certain medications), be able to undergo MRI and PSMA PET scans without contraindications like incompatible implants, and not have severe urinary problems or conditions preventing radiotherapy.

Inclusion Criteria

I am older than 18 years.

My prostate cancer has been confirmed by a tissue examination.

My prostate cancer is classified as high-intermediate, high, or very-high risk.

Exclusion Criteria

I cannot undergo intense prostate radiotherapy due to certain health conditions like connective tissue disease.

My cancer has spread beyond the pelvic area.

I have had prostate cancer treatment, but not hormone therapy before joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive image-guided SBRT using fiducial markers for intra-fraction motion management with dose escalation to imaging defined targets

5 fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of 6-week and 6-month toxicity

6 months

Long-term Follow-up

Participants are monitored for quality of life and disease-free survival over a 5-year period

5 years

What Are the Treatments Tested in This Trial?

Interventions

• PSMA MRI Guided Prostate SBRT

Trial Overview The trial is testing a targeted radiation therapy called SBRT guided by PSMA PET scans and mpMRI images in men with specific risk levels of prostate cancer. It involves fusing these images with CT simulations for precise tumor targeting, using fiducial markers for motion management during treatment, and escalating doses to identified targets while protecting surrounding organs.

How Is the Trial Designed?

Group I: Men with high intermediate to very high risk prostate cancer Experimental Treatment 4 Interventions

Men with high intermediate to very high risk prostate cancer

PSMA MRI Guided Prostate SBRT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as PSMA MRI Guided Prostate SBRT for:

• High intermediate-risk prostate cancer
• High-risk prostate cancer
• Very high-risk prostate cancer

Approved in United States as PSMA MRI Guided Prostate SBRT for:

• High intermediate-risk prostate cancer
• High-risk prostate cancer
• Very high-risk prostate cancer

Approved in Canada as PSMA MRI Guided Prostate SBRT for:

• High intermediate-risk prostate cancer
• High-risk prostate cancer
• Very high-risk prostate cancer

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

668

Recruited

424,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Published Research Related to This Trial

In a study involving 12 prostate cancer patients, the new tracer 18 F-PSMA-1007 demonstrated high uptake in organs such as the liver, kidneys, and salivary glands, indicating its potential effectiveness for imaging prostate cancer.

The effective radiation dose from 18 F-PSMA-1007 was calculated to be between 6.0-8.0 mSv for an average patient, which provides important safety information for its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biokinetics and dosimetry of 18 F-PSMA-1007 in patients with prostate cancer. Hvittfeldt, E., Bjöersdorff, M., Brolin, G., et al.[2023]

In a pilot study of 62 patients with suspected or defined prostate cancer, PSMA-PET/MRI imaging led to a change in management strategies for 41.9% of patients, indicating its potential clinical utility in guiding treatment decisions.

The most significant impact of PSMA-PET/MRI was observed in patients with biochemical recurrent prostate cancer, particularly those with PSA levels between 0.5 and 1 ng/ml, suggesting that this imaging technique can help refine treatment approaches in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. Liu, A., Zhang, M., Huang, H., et al.[2022]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., et al.[2023]

The study demonstrated that a comprehensive whole-body 18F-PSMA-1007-PET/MRI protocol is feasible and reproducible for imaging prostate cancer in eight high-risk patients, effectively detecting dominant lesions and providing complementary staging information.

The results showed strong correlation between SUVmean values from PET/CT and PET/MRI, indicating that this combined imaging approach can enhance the accuracy of prostate cancer assessment while minimizing artifacts, thus improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. Freitag, MT., Kesch, C., Cardinale, J., et al.[2019]

In a study of 64 patients with prostate cancer local recurrences treated with single-fraction stereotactic body radiotherapy (SBRT), PSA levels significantly decreased after treatment, indicating effective tumor control.

The treatment showed promising safety and efficacy, with a 3-year progression-free survival rate of 51.2% and only 9% of patients experiencing mild toxicities, suggesting that SBRT can be a viable option for patients with prior treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-fraction prostate-specific membrane antigen positron emission tomography- and multiparametric magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer local recurrences. Ehret, F., Hofmann, T., Fürweger, C., et al.[2023]

A systematic review of 15 studies involving 853 patients found that 18F-PSMA-1007 PET/CT or PET/MRI has a high detection rate of 81.3% for biochemical recurrent prostate cancer, even in patients with low PSA levels.

The detection rate of 18F-PSMA-1007 imaging is influenced by serum PSA values, indicating that higher PSA levels may correlate with better detection outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-PSMA-1007 PET in Biochemical Recurrent Prostate Cancer: An Updated Meta-Analysis. Ferrari, M., Treglia, G.[2022]

PSMA-targeted PET/CT is a highly sensitive and specific imaging technique that significantly improves the detection and management of recurrent prostate cancer compared to conventional imaging methods.

This advanced imaging allows for better patient selection for localized salvage therapies and has shown promise in delaying the need for systemic treatments in patients with oligometastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-specific membrane antigen targeted PET/CT for recurrent prostate cancer: a clinician's guide. Young, S., Liu, W., Zukotynski, K., et al.[2022]

In a study of 13 men with localized prostate cancer, combining PSMA-directed PET and mpMRI imaging revealed that over half of the identified lesions (53.8%) were discordant, meaning they were detected by only one of the imaging methods, highlighting the importance of using both for comprehensive disease identification.

Planning radiation therapy using both imaging techniques resulted in better coverage of all identified lesions while maintaining safety limits for surrounding tissues, suggesting that this combined approach could enhance treatment effectiveness for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using 18F-DCFPyL Prostate-Specific Membrane Antigen-Directed Positron Emission Tomography/Magnetic Resonance Imaging to Define Intraprostatic Boosts for Prostate Stereotactic Body Radiation Therapy. Floberg, JM., Wells, SA., Ojala, D., et al.[2023]

In a study involving 20 patients with castration-sensitive oligorecurrent prostate cancer, PSMA-PET/CT guided SBRT using a 1.5 T MRI-Linac was found to be safe and well tolerated, with no acute severe toxicities reported.

The treatment resulted in a significant reduction in PSA levels, with 6 patients showing a partial response and 10 achieving a complete response, indicating promising effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for oligometastatic castration sensitive prostate cancer using 1.5 T MRI-Linac: preliminary data on feasibility and acute patient-reported outcomes. Mazzola, R., Cuccia, F., Figlia, V., et al.[2021]

In a study of 35 patients with locally recurrent prostate cancer, PSMA PET and MRI-guided stereotactic body radiotherapy (SBRT) resulted in a median progression-free survival of 52.2 months, indicating effective long-term disease control.

The treatment was associated with low rates of toxicity, as 54.3% of patients experienced no acute side effects and 79.4% had no late toxicity, making it a safer alternative to more invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA PET-based stereotactic body radiotherapy for locally recurrent prostate cancer after definitive first-line therapy. Gruen, A., Tegel, K., Kluge, A., et al.[2023]

Citations

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PSMA MRI Guided prOstate SBRT (ARGOS)/ ... The study aims to assess the safety and effectiveness of stereotactic body radiation therapy (SBRT) boosting of DILs and positive lymph nodes defined by [18F] ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/10/23/jnumed.125.269818

Efficacy of [18F]PSMA-1007 PET/CT in Primary Staging of ... Efficacy of [18F]PSMA-1007 PET/CT in Primary Staging of Prostate Carcinoma: A Systematic Review and Metaanalysis. Kambiz Rahbar, Frederik L.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11905080/

[18F]PSMA-1007 PET/MR as a Precision Biomarker for ... PSMA-PETMR significantly improves the detection of recurrent PCa in patients with very low PSA levels, offering precise lesion localization and supporting ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.231879

Multiparametric MRI and 18F-PSMA-1007 PET/CT for the ... 18 F-PSMA-1007 PET/CT showed good sensitivity and moderate specificity for the detection of csPCa and ruled this out in 93% of participants with PI-RADS 3 ...

5. bmcmedimaging.biomedcentral.com bmcmedimaging.biomedcentral.com/articles/10.1186/s12880-024-01376-4

A comparative study of 18F-PSMA-1007 PET/CT and pelvic ... Compared with MRI, 18 F-PSMA-1007 PET/CT has higher sensitivity and diagnostic accuracy in the detection of malignant prostate tumors.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429625000475

PSMA-PET Guided Radiotherapy in Prostate Cancer The synergy between PSMA-PET and radiotherapy enables a more effective therapeutic approach across both early and advanced stages of PCa.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453091/

Prostate MRI and PSMA-PET in the Primary Diagnosis of ... This review summarizes the current main evidence on the role of prostate MRI and PSMA-PET as tools for the primary diagnosis of csPCa.