Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer

(DASBRT-RPC Trial)

Overseen By Michael Cummings, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Rochester

Disqualifiers: Metastatic disease, Prior pelvic radiation, others

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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7.5 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of radiation therapy for men whose prostate cancer has returned after surgery. Stereotactic Body Radiation Therapy (SBRT) delivers large doses of radiation in a short time, unlike traditional methods that take weeks. The trial evaluates the effectiveness of this treatment and its potential to reduce side effects, using advanced imaging and AI technology. Men who have undergone prostate surgery and show signs of cancer returning in the surgical area or pelvic nodes may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative therapy.

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 Daily-adaptive Stereotactic Body Radiation Therapy is safe for recurrent prostate cancer?

Research has shown that daily-adaptive stereotactic body radiation therapy (SBRT) is generally manageable for patients. In one study with 22 participants who received a similar treatment, most coped well. Reported side effects were mild, such as fatigue and minor skin irritation, with no serious side effects directly linked to the treatment. Although this trial remains in the early stages, initial results appear promising regarding safety. SBRT is already a well-known treatment for primary prostate cancer, suggesting reasonable safety. However, as with any new treatment, some uncertainty remains, and ongoing studies aim to confirm these early findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about daily-adaptive Stereotactic Body Radiation Therapy (SBRT) for recurrent prostate cancer because it offers a highly precise and targeted approach to radiation. Unlike traditional radiation therapies, which can affect surrounding healthy tissues, this technique adapts to daily anatomical changes, minimizing damage to non-cancerous areas. This precision not only aims to enhance the effectiveness of the treatment by concentrating radiation on cancer cells but also reduces side effects, potentially improving the quality of life for patients.

What evidence suggests that Daily-adaptive Stereotactic Body Radiation Therapy might be an effective treatment for recurrent prostate cancer?

Research has shown that stereotactic body radiation therapy (SBRT) for prostate cancer looks promising. This trial will evaluate SBRT for patients with recurrent prostate cancer, specifically those with recurrence in the prostate bed or pelvic nodal region. Studies have found that SBRT can accurately target cancer cells, reducing the number of treatment sessions needed. Patients who received adaptive SBRT demonstrated good results, with effective control of returning prostate cancer. Advances in imaging and AI technology make treatments more precise, helping to reduce side effects. While evidence is still growing for using SBRT after surgery, its success in treating initial prostate cancer suggests it could also work well for recurrent cases. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men who've had prostate cancer surgery but now have signs it's back. They need two PSA tests showing a level over 0.02 ng/dl, taken at least 30 days apart. Men with bowel inflammation, recent GI or urinary issues, high PSA levels (>10 ng/dl), spread of cancer beyond the pelvis, or previous pelvic radiation can't join.

Inclusion Criteria

I had surgery for prostate cancer.

My prostate cancer has returned in the area where my prostate was or nearby lymph nodes.

At least two serum detectable PSA levels defined as >0.02 ng/dl at least 30 days apart.

Exclusion Criteria

I was hospitalized for a urinary problem in the last 3 months.

I was hospitalized for a stomach or intestine problem in the last 3 months.

PSA >10 ng/dl at study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Initial toxicity assessment phase to evaluate the safety of the novel radiation treatment schema

1-2 years

Treatment

Participants receive Daily-Adaptive with AI-assisted SBRT using Ethos Plan Adaptive technology

7.5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of biochemical recurrence free survival and long-term side effects

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Daily-adaptive Stereotactic Body Radiation Therapy

Trial Overview

The study is testing a new way to do radiation called Daily-adaptive Stereotactic Body Radiation Therapy (SBRT) using AI and Ethos Plan Adaptive technology. It aims to treat recurrent prostate cancer after surgery more precisely in fewer sessions than traditional methods.

How Is the Trial Designed?

Group I: 2- Pelvic nodal with or without a prostate bed recurrence Experimental Treatment 1 Intervention

Patients who have a radiologic recurrence of prostate cancer in the pelvic node region

Group II: 1 - Prostate bed only recurrence Experimental Treatment 1 Intervention

Patients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.

Daily-adaptive Stereotactic Body Radiation Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Primary prostate cancer
• Recurrent prostate cancer

Approved in United States as Stereotactic Body Radiation Therapy for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• Recurrent prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Primary prostate cancer
• Recurrent prostate cancer

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

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]

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]

Stereotactic body radiotherapy (SBRT) shows a high local control rate of 98.1% in treating oligorecurrent prostate cancer limited to lymph nodes, based on a systematic review of 363 patients across nine studies with a median follow-up of 19.23 months.

The treatment demonstrated a low incidence of toxicity, with only 5.6% of patients experiencing grade ≥2 adverse effects, and no cases of grade 4 toxicity, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. Ponti, E., Lancia, A., Ost, P., et al.[2022]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed a high two-year biochemical relapse-free survival rate of 99%, indicating its efficacy in controlling the disease.

The treatment was well tolerated, with low rates of gastrointestinal (1%) and genitourinary (31%) toxicities, and most patients who were sexually potent before treatment maintained their potency two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Chen, LN., Suy, S., Uhm, S., et al.[2022]

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]

Stereotactic body radiation therapy (SBRT) was administered to 16 patients with isolated prostate cancer recurrence, resulting in a significant biochemical response in 15 out of 16 patients at a median follow-up of 10 months.

The treatment was well tolerated, with only one patient experiencing mild acute toxicity, indicating that SBRT is a safe option for managing isolated recurrences in the prostatic bed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic radiotherapy for isolated recurrence in the prostatic bed. Detti, B., Bonomo, P., Masi, L., et al.[2018]

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]

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]

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]

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 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 involving 44 prostate cancer patients, both multileaf collimator (MLC) tracking and beam gating were effective in delivering accurate doses during Stereotactic Ablative Radiotherapy (SABR), improving treatment precision compared to no motion adaptation.

While both methods showed similar dosimetric performance, MLC tracking had the advantage of fewer treatment interruptions compared to gating, which required an average of 0.5 couch shifts and caused delays of about 1.8 minutes per fraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is multileaf collimator tracking or gating a better intrafraction motion adaptation strategy? An analysis of the TROG 15.01 stereotactic prostate ablative radiotherapy with KIM (SPARK) trial. Hewson, EA., Nguyen, DT., O'Brien, R., et al.[2022]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S2405630825001296

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Stereotactic ablative radiotherapy (SABR) is a salvage option for locally recurrent prostate cancer (LRPC); however, challenges remain.

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thegreenjournal.com

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Adoption of hypofractionation radiotherapy for localised prostate cancer and quality of life outcomes in an Australian population-based cohort

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To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT ...

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withpower.com

withpower.com/trial/phase-2-prostatic-neoplasms-10-2023-1e9c0

Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer

This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt ...