SABR for Metastatic Prostate Cancer

(ANCHORProstate Trial)

Overseen By Mom Phat

Age: Any Age

Sex: Male

Trial Phase: Phase 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether SABR, a focused radiation therapy, can benefit men with metastatic prostate cancer when added to standard treatments. The goal is to determine if SABR can improve progression-free survival in men whose cancer has spread but remains responsive to hormone therapy. Participants with stable PSA levels, a blood marker for prostate cancer, after initial treatment and 1-5 cancer spots detected on a PSMA-PET scan may be suitable candidates. The trial compares men receiving SABR with those who do not, to assess any notable differences. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing treatment, as the trial involves patients who have already achieved a stable response to their current therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Stereotactic Ablative Body Radiotherapy (SABR) is generally well-tolerated by patients. One study used SABR to treat areas where cancer had spread to bones and lymph nodes, and only 13.1% of patients required medical attention for issues. Another study suggested that SABR can be safe, with nearly half of the participants avoiding additional hormone therapy for two years. These findings indicate that SABR is a safe option for treating metastatic prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about SABR (stereotactic ablative radiotherapy) for metastatic prostate cancer because it offers a highly precise way to target tumors with intense doses of radiation. Unlike traditional treatments like hormone therapy or chemotherapy, which can affect the whole body, SABR focuses directly on cancer sites, potentially reducing side effects and sparing healthy tissues. This precision could lead to more effective local control of the cancer, offering hope for improved outcomes in patients with metastatic prostate cancer.

What evidence suggests that SABR could be an effective treatment for metastatic prostate cancer?

Research has shown that SABR, a precise radiation therapy, can effectively treat prostate cancer that has spread. One study found that SABR improved outcomes for patients with a few cancer spots, helping to control the disease. Another study showed promising results with few side effects for both hormone-sensitive and hormone-resistant prostate cancer. Early findings also suggest that SABR can effectively target cancer that has spread to bones and lymph nodes. In this trial, some participants will receive SABR consolidation, while others will be in a control group without it. These results indicate that SABR could be a helpful treatment option for those with metastatic prostate cancer. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men with metastatic prostate cancer who are part of the PERa registry and have shown the best possible response to standard treatments, as seen by stable PSA levels. They should be able to perform daily activities (ECOG 0-2) and have a PSA greater than 0.2 ng/mL. Only those with 1-5 areas of cancer detectable on PSMA-PET scans that can be targeted by SABR will qualify.

Inclusion Criteria

I have 1-5 areas of cancer visible on a PSMA-PET scan that can be treated with targeted radiation.

PSA > 0.2 ng/mL

I can take care of myself and perform daily activities.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive experimental SABR based on PSMA-PET detected disease after maximal systemic response

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Long-term follow-up

Participants are monitored for long-term outcomes such as toxicity and progression

5 years

What Are the Treatments Tested in This Trial?

Interventions

• SABR

Trial Overview The ANCHOR-Prostate trial is testing whether adding a type of precise radiation therapy called SABR (Stereotactic Ablative Radiotherapy) after maximum response from usual drug treatments can help control prostate cancer better. The main goal is to see if patients remain free from disease progression one year after treatment.

How Is the Trial Designed?

Group I: SABR consolidation Experimental Treatment 1 Intervention

Group II: Control - no SABR consolidation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is an advanced treatment that delivers high doses of radiation in fewer sessions while protecting surrounding healthy tissues, making it effective for small tumors in various locations, including the prostate.

SABR is becoming a standard treatment for low and intermediate-risk prostate cancer, supported by research from Sunnybrook and the US prostate SABR consortium, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. Musunuru, HB., Cheung, P., Loblaw, A.[2022]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

In a study of 713 men treated with stereotactic body radiation therapy (SBRT) for localized prostate cancer, only 3% to 4% experienced significant long-term declines in health-related quality of life (HRQOL), indicating that SBRT has minimal long-term negative effects on overall well-being.

Factors such as lower baseline bowel HRQOL and depression were found to predict declines in HRQOL, suggesting that comorbid conditions may play a larger role in patient outcomes than the treatment itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer. Dess, RT., Jackson, WC., Suy, S., et al.[2022]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

In a study of 152 men with intermediate risk prostate cancer, weekly stereotactic ablative radiotherapy (SABR) resulted in better short-term bowel and urinary quality of life compared to every other day treatment, but there were no significant differences in late toxicity or long-term quality of life outcomes after 62 months.

Both treatment regimens showed similar rates of biochemical failure and overall survival, indicating that while weekly SABR may reduce acute side effects, it does not compromise long-term efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT). Alayed, Y., Quon, H., Ong, A., et al.[2021]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

In a study of 87 men with oligometastatic prostate cancer treated with stereotactic ablative radiotherapy (SABR), the median disease-free survival (DMFS) was 21.8 months for hormone-sensitive patients, indicating a significant benefit from this treatment.

Combining SABR with short-term androgen-deprivation therapy improved both biochemical progression-free survival (bPFS) and DMFS in patients with oligorecurrent hormone-sensitive prostate cancer, suggesting a potential strategy for enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. Mercier, C., Claessens, M., De Troyer, B., et al.[2022]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

In a study of 20 men with oligometastatic prostate cancer treated with stereotactic ablative body radiotherapy (SABR), 60% experienced a decline in PSA levels, indicating a positive response to the treatment.

The study found a 12-month local progression-free survival rate of 93% and a distant progression-free survival rate of 62%, suggesting that SABR is effective in managing oligometastatic prostate cancer identified through PSMA-PET/CT imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-specific membrane antigen-positron emission tomography/computed tomography (PSMA-PET/CT)-guided stereotactic ablative body radiotherapy for oligometastatic prostate cancer: a single-institution experience and review of the published literature. Ong, WL., Koh, TL., Lim Joon, D., et al.[2020]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043737/

Stereotactic ablative body radiotherapy in patients with ... Early outcomes of SABR look very promising. In the pHART3 study, routine biopsies were done 3 years post-treatment. Seventy-one of 74 (96%) of eligible patients ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125000860

Long-term Oncological Outcomes in the Phase 2 PATRIOT ... This study suggests no significant differences in long-term cancer outcomes between EOD and QW schedules for five-fraction prostate SABR.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025052235

Stereotactic ablative body radiotherapy for PSMA-PET/CT ... 213 patients were included for analysis. 41.3 % of SABR was delivered to bone and 49.3 % to nodal metastases, with 28 patients (13.1 %) having ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2763312

Outcomes of Observation vs Stereotactic Ablative ... Conclusions and Relevance Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10990008/

Stereotactic ablative radiation therapy in metastatic ... Treating omPCa with SABR MDT appears to generate an efficacy signal with minimal morbidity across both hormone-sensitive and castration-resistant disease.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06325046

Adaptive Radiation Therapy (ART) Stereotactic Ablative ... This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30227924/

Stereotactic Abative Body Radiotherapy (SABR) for ... The approach was found to be safe with avoidance of hormone therapy in almost half of the participants at 2 yr.