Adaptive Radiotherapy for Prostate Cancer

(EASY Trial)

Overseen By Andrew McPartlin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Prior radiotherapy, Secondary malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Adaptive radiotherapy using SBRT for prostate cancer?

Research shows that adaptive radiotherapy using SBRT for prostate cancer can improve the accuracy of targeting the cancer while reducing exposure to nearby healthy organs. This is achieved by adjusting the treatment plan daily to account for changes in the position of the prostate and surrounding organs, potentially leading to better outcomes and fewer side effects. ^{1 2 3 4 5}

Is adaptive radiotherapy using SBRT safe for humans?

Research on adaptive radiotherapy using SBRT for prostate cancer suggests it aims to reduce treatment-related side effects by adjusting to changes in the body during treatment. Studies have looked at minimizing toxicity, particularly to the bowel and rectum, indicating a focus on safety in its application. ^{1 2 6 7 8}

How is adaptive radiotherapy using SBRT different from other treatments for prostate cancer?

Adaptive radiotherapy using SBRT for prostate cancer is unique because it adjusts the radiation plan daily to account for changes in the prostate's position and size, improving accuracy and reducing damage to nearby healthy tissues. This approach uses advanced imaging techniques, like CT or MRI, to ensure precise targeting, which is not typically done in standard radiation treatments. ^{1 2 4 5 9}

What is the purpose of this trial?

This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.

Eligibility Criteria

This trial is for men with prostate cancer who have a small number of affected lymph nodes near the aorta or iliac arteries, confirmed by advanced imaging. They should be relatively healthy and active (ECOG 0-2) and not have had previous radiation in that area, significant other illnesses, or another active cancer besides non-melanoma skin cancer.

Inclusion Criteria

My scan shows 10 or fewer affected lymph nodes near my aorta.

I have a few cancer spots near my aorta or iliac arteries set for targeted radiation.

My prostate cancer was confirmed through a tissue examination.

Exclusion Criteria

I cannot undergo radiation therapy due to health reasons.

I have had radiation therapy to lymph nodes in my chest or pelvis.

I do not have health issues that would prevent me from receiving radiotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions

5 fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life and adverse events

2 years

Treatment Details

Interventions

• Adaptive radiotherapy using SBRT

Trial Overview The study is testing adaptive radiotherapy using SBRT (a precise form of radiation therapy) on patients with limited spread of prostate cancer to certain lymph nodes. It's designed to see how feasible this targeted approach is for controlling these specific areas of metastasis.

Participant Groups

Group I: SBRT delivered with CBCT-guided online adaptive RT Experimental Treatment 1 Intervention

Patients will undergo CT guided online adaptive SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25Gy in 5 fractions ENI to PA nodes (+/- pelvic nodes).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study involving 7 patients with localized prostate cancer, the use of AI-augmented online adaptive radiotherapy (ART) significantly improved target coverage (PTV V100) for prostate SBRT, with increases of up to 21.4% for higher dose targets, indicating enhanced treatment efficacy.

The adaptive treatment plans also significantly reduced the dose to the rectum by an average of 38.8 cGy per fraction, improving safety, while still meeting bladder dose constraints, suggesting a favorable therapeutic ratio without increasing the risk of severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT-based online adaptive radiotherapy improves target coverage and organ at risk (OAR) avoidance in stereotactic body radiation therapy (SBRT) for prostate cancer. Waters, M., Price, A., Laugeman, E., et al.[2023]

Online MR-guided adaptive re-planning for prostate cancer SBRT showed a dosimetric benefit in 90% of the ten healthy male volunteers, improving target coverage without increasing radiation exposure to surrounding organs, particularly the rectum.

The benefits of this adaptation were stable for up to 45 minutes, but after 60 minutes, coverage dropped below acceptable levels in 30% of cases, suggesting the need for verification imaging before treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrafractional stability of MR-guided online adaptive SBRT for prostate cancer. Schaule, J., Chamberlain, M., Wilke, L., et al.[2022]

In a study of 14 patients with low-volume metastatic prostate cancer treated with MR-guided adaptive prostate SBRT (SMART), the treatment was well tolerated, with only one patient experiencing mild urinary toxicity and no significant gastrointestinal side effects.

At a median follow-up of 29 months, 11 out of 14 patients maintained local control of their disease, indicating that SMART is an effective and low-risk option for prostate-directed radiotherapy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided prostate SBRT in prostate cancer patients with low-volume metastatic disease. Moningi, S., Choudhury, AD., Martin, NE., et al.[2023]

In a study involving 11 patients and 55 MRI scans, it was found that while the target area (CTV) for radiation therapy remained stable, significant changes occurred in the bladder and rectum volumes, which could affect treatment outcomes.

The use of stereotactic MRI guided adaptive radiotherapy (SMART) was shown to improve dosimetry for 78.2% of treatment fractions, helping to ensure that radiation targets were adequately covered while minimizing exposure to surrounding organs at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interfractional Geometric Variations and Dosimetric Benefits of Stereotactic MRI Guided Online Adaptive Radiotherapy (SMART) of Prostate Bed after Radical Prostatectomy: Post-Hoc Analysis of a Phase II Trial. Cao, M., Gao, Y., Yoon, SM., et al.[2021]

In a study of 40 lung SBRT patients, adaptive planning significantly reduced radiation dose to organs-at-risk (OARs) compared to nonadaptive plans, indicating improved safety for surrounding tissues during treatment.

The effectiveness of adaptive planning was correlated with changes in tumor volume and distances to OARs, suggesting that larger tumor shrinkage during treatment can lead to better dosimetric outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive stereotactic body radiation therapy planning for lung cancer. Qin, Y., Zhang, F., Yoo, DS., et al.[2018]

In a study of 254 patients with low-to-intermediate risk prostate cancer undergoing 5-fraction SBRT, significant prostate volume changes were observed, with a mean increase of 6.4% and swelling in 50% of cases.

Despite the prostate volume changes, there was no correlation between these changes and treatment toxicity as measured by patient-reported outcomes, indicating that the adaptive treatment strategy effectively managed volume variations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate volume variation during 1.5T MR-guided adaptive stereotactic body radiotherapy (SBRT) and correlation with treatment toxicity. Nicosia, L., Ravelli, P., Rigo, M., et al.[2023]

In a study of 103 patients undergoing stereotactic body radiation therapy (SBRT) for localized prostate cancer, 52% experienced a significant decline in bowel-related quality of life within one week, while 27.5% developed grade 2 or higher rectal toxicity.

Key dosimetric predictors of acute rectal toxicity were identified, specifically rectal D19% and V20Gy, which can help clinicians adjust treatment plans to reduce the risk of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric predictors of acute bowel toxicity after Stereotactic Body Radiotherapy (SBRT) in the definitive treatment of localized prostate cancer. Repka, MC., Carrasquilla, M., Paydar, I., et al.[2023]

Stereotactic body radiation therapy (SBRT) resulted in significantly lower post-treatment PSA levels compared to intensity-modulated radiation therapy (IMRT) at 2 and 3 years, indicating better efficacy in controlling prostate cancer.

Both SBRT and IMRT showed similar overall survival rates after 5 years, but SBRT offers advantages such as lower cost and easier application, making it a suitable alternative for treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. Gao, QN.[2022]

In a study involving 20 prostate cancer patients treated with Adaptive Stereotactic Body Radiotherapy (SBRT), the delivered dose was confirmed to be adequate, ensuring that the target area received at least 95% of the prescribed dose while minimizing exposure to surrounding organs.

The study demonstrated that both the daily re-computed doses and cumulative doses were consistent, indicating that the online MRI guidance effectively maintained treatment accuracy despite potential prostate motion during the longer session times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive SBRT by 1.5 T MR-linac for prostate cancer: On the accuracy of dose delivery in view of the prolonged session time. Ruggieri, R., Rigo, M., Naccarato, S., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

CT-based online adaptive radiotherapy improves target coverage and organ at risk (OAR) avoidance in stereotactic body radiation therapy (SBRT) for prostate cancer. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Intrafractional stability of MR-guided online adaptive SBRT for prostate cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

MR-guided prostate SBRT in prostate cancer patients with low-volume metastatic disease. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Interfractional Geometric Variations and Dosimetric Benefits of Stereotactic MRI Guided Online Adaptive Radiotherapy (SMART) of Prostate Bed after Radical Prostatectomy: Post-Hoc Analysis of a Phase II Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Adaptive stereotactic body radiation therapy planning for lung cancer. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Prostate volume variation during 1.5T MR-guided adaptive stereotactic body radiotherapy (SBRT) and correlation with treatment toxicity. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Dosimetric predictors of acute bowel toxicity after Stereotactic Body Radiotherapy (SBRT) in the definitive treatment of localized prostate cancer. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Adaptive SBRT by 1.5 T MR-linac for prostate cancer: On the accuracy of dose delivery in view of the prolonged session time. [2021]