80 Participants Needed

Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer

(DASBRT-RPC Trial)

MC
Overseen ByMichael Cummings, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. 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 treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. 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 to maintain control and minimize side effects.

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

Research suggests that Stereotactic Ablative Radiotherapy (SABR), a component of the treatment, can improve survival and delay further spread of cancer in patients with oligometastatic prostate cancer, indicating its potential effectiveness for recurrent prostate cancer.12345

Is Stereotactic Body Radiation Therapy (SBRT) safe for treating prostate cancer?

Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR), has been shown to be generally safe and well-tolerated in treating prostate cancer, with careful planning and setup techniques. However, long-term safety data, especially at higher doses, is still limited.26789

How is Daily-Adaptive SBRT different from other treatments for recurrent prostate cancer?

Daily-Adaptive SBRT is unique because it delivers high doses of radiation in fewer sessions, which can be more effective and convenient compared to traditional radiation therapy that uses lower doses over more sessions. This approach is particularly beneficial for targeting specific areas of recurrent prostate cancer, potentially improving outcomes and reducing the need for hormone therapy.23101112

Eligibility Criteria

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.
See 1 more

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
See 3 more

Timeline

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

Treatment Details

Interventions

  • Daily-adaptive Stereotactic Body Radiation Therapy
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 2- Pelvic nodal with or without a prostate bed recurrenceExperimental Treatment1 Intervention
Patients who have a radiologic recurrence of prostate cancer in the pelvic node region
Group II: 1 - Prostate bed only recurrenceExperimental Treatment1 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

Find a Clinic Near You

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

Findings from Research

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

References

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]
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]
Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]
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. [2022]
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]
Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]
Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]
Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. [2022]
Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]
CyberKnife stereotactic radiotherapy for isolated recurrence in the prostatic bed. [2018]