Stereotactic Body Radiation Therapy for Recurrent Prostate Cancer
(DASBRT-RPC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Rochester
Disqualifiers: Metastatic disease, Prior pelvic radiation, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
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.
12345Is 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.
26789How 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.
23101112Eligibility 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.
+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
+3 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Wilmot Cancer Institute - Dept of Radiation OncologyRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
Varian Medical SystemsIndustry Sponsor
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]Adaptive Stereotactic Body Radiotherapy (SBRT) of prostate cancer (PC) by online 1.5 T MRi-guidance prolongs session-time, due to contouring and planning tasks, thus increasing the risk of prostate motion. Hence, the interest to verify the adequacy of the delivered dose.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available.
Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]The addition of stereotactic ablative radiotherapy (SABR) to standard of care for patients with oligometastatic prostate cancer has the potential of improving survival and delaying further metastases. The primary aim of this analysis is to report survival outcomes and pattern of recurrence of patients with hormone-sensitive (HSPC) and castrate-resistant (CRPC) oligometastatic prostate cancer treated with SABR.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.
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]Stereotactic Ablative Radiotherapy (SABR) has recently emerged as a favourable treatment option for prostate cancer patients. With higher doses delivered over fewer fractions, motion adaptation is a requirement for accurate delivery of SABR. This study compared the efficacy of multileaf collimator (MLC) tracking vs. gating as a real-time motion adaptation strategy for prostate SABR patients enrolled in a clinical trial.
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]Stereotactic ablative body radiotherapy (SABR) is a newer method of ultra hypo fractionated radiotherapy that uses combination of image-guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT), to deliver high doses of radiation in a few fractions to a target, at the same time sparing the surrounding organs at risk (OAR). SABR is ideal for treating small volumes of disease and has been introduced in a number of disease sites including brain, lung, liver, spine, and prostate. Given the radiobiological advantages of treating prostate cancer with high doses per fraction, SABR is becoming a standard of care for low and intermediate-risk prostate cancer patients based upon the results from Sunnybrook and also the US-based prostate SABR consortium. This review examines the development of moderate and ultra hypo-fractionation schedules at the Odette Cancer centre, Sunnybrook Health Sciences. Moderate hypo-fractionation protocol was first developed in 2001 for intermediate-risk prostate cancer and from there on different treatment schedules including SABR evolved for all risk groups.
Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]Stereotactic ablative radiotherapy (SABR) is a relatively novel form of high precision radiotherapy. For low- and intermediate risk patients, ultrahypofractionation (UHF - more than 5 Gy per day) has been compared to conventionally fractionated or moderately hypofractionated radiotherapy in two large randomized studies. A third smaller randomized study examined the question of the optimal frequency of treatments. The results of these studies will be reviewed. SABR for high risk prostate cancer has been shown to be feasible and is well tolerated with careful planning and setup techniques. However, there is currently insufficient data supporting its use for high-risk patients to offer SABR outside of a clinical trial. SABR costs less to the radiotherapydepartments and, the patient, as well as increasing system capacity. Therefore, it has the potential to be widely adopted in the next few years.
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy. Optimal doses remain poorly defined with limited prospective comparative trials and long-term safety/efficacy data at higher dose levels. We analyzed toxicity and outcomes for SAbR in men with localized PCa at escalated 45 Gy in 5 fractions.
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 radiotherapy (SBRT) is emerging as a treatment option in patients affected by oligorecurrent prostate cancer disease limited to lymph nodes, a subgroup of patients who would otherwise be treated only with androgen deprivation therapy (ADT).
Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]Stereotactic body radiation therapy (SBRT) delivers fewer high-dose fractions of radiation which may be radiobiologically favorable to conventional low-dose fractions commonly used for prostate cancer radiotherapy. We report our early experience using SBRT for localized prostate cancer.
CyberKnife stereotactic radiotherapy for isolated recurrence in the prostatic bed. [2018]To report a clinical experience of stereotactic body radiation therapy (SBRT) for isolated recurrence in the prostatic bed from prostate cancer.