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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation treatment for prostate cancer that has spread to specific lymph nodes, which are small glands in the immune system. The goal is to determine if adaptive radiotherapy, a type of targeted radiation, is feasible and effective. This trial targets individuals with prostate cancer that is locally controlled but has spread to a few lymph nodes in the para-aortic or common iliac areas, as identified by special imaging tests. Participants must have a confirmed diagnosis of prostate cancer with limited spread to no more than ten specific lymph nodes. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this adaptive radiotherapy using SBRT is safe for prostate cancer patients?

Research has shown that adaptive radiotherapy using SBRT (Stereotactic Body Radiation Therapy) is generally safe and well-tolerated. In past studies, most patients experienced only mild side effects, with serious side effects being rare. Specifically, fewer than 15% of patients experienced severe side effects related to urinary organs. Another study found that this treatment did not significantly affect quality of life, indicating a strong safety record.

Overall, the treatment has proven effective with manageable side effects, even years after treatment. This suggests that SBRT is a safe option for those considering participation in this type of clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about adaptive radiotherapy using SBRT for prostate cancer because it offers a tailored approach to treatment. Unlike traditional radiotherapy, which uses a fixed plan, adaptive radiotherapy adjusts the radiation dose based on the tumor's size and position in real-time. This method, guided by Cone Beam CT, allows for more precise targeting of the cancer, potentially reducing damage to surrounding healthy tissue and minimizing side effects. The promise of delivering a higher, more effective radiation dose in fewer sessions (5 fractions) is another reason this approach stands out, potentially leading to better outcomes and a more convenient treatment schedule for patients.

What evidence suggests that adaptive radiotherapy using SBRT might be an effective treatment for prostate cancer?

Research has shown that adaptive radiotherapy, specifically stereotactic body radiotherapy (SBRT), works well for some prostate cancers. In this trial, participants will receive SBRT delivered with CBCT-guided online adaptive RT. One study found that SBRT provides excellent control over the cancer, with a low chance of recurrence within five years. Another study demonstrated that online adaptive SBRT helps the radiation focus better on the tumor while reducing exposure to nearby organs, such as the rectum. This precision makes the treatment safer, with fewer possible side effects. Overall, SBRT is considered a promising treatment for prostate cancer, especially when the cancer has spread to nearby lymph nodes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

My prostate cancer was confirmed through a tissue examination.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12117833/

Online adaptive stereotactic body radiotherapy for ... The PACE-B RCT demonstrated that SBRT results in excellent oncological outcomes with a 5-year biochemical and biochemical progression-free ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630823001180

CT-based online adaptive radiotherapy improves target ... CT-based online adaptive SBRT resulted in statistically significant and clinically meaningful improvements in PTV coverage and D0.03 cc dose to the rectum.

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Men who received the shortened treatment, called stereotactic body radiotherapy (SBRT), did not have a higher risk of cancer recurrence over the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05628363

Adaptive Stereotactic Body Radiation Therapy to the ... This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00264-1/fulltext

First-in-Men Online Adaptive Robotic Stereotactic Body ... This paper focuses on the development, preclinical validation, and clinical testing of online adaptive robotic stereotactic body radiation therapy for this ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S240563082400048X

Stereotactic ultrahypofractionated MR-guided radiotherapy ... Daily online-adaptive MRgSBRT for localized prostate cancer resulted in an excellent overall toxicity profile without any major negative impact on quality of ...

7. advancesradonc.com advancesradonc.com/article/S2452-1094(24)00137-4/fulltext

Acute and Late Patient-Reported Toxicity Outcomes Our study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... Conclusion. SBRT is a safe and effective treatment with an encouraging bPFS rate and tolerable toxicity for localized PCa patients. Patients with a Gleason ...