SABR for Metastatic Prostate Cancer
(ANCHORProstate Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?A phase IIR cmRCT trial companion to PERa registry, investigating the merit of SABR consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental SABR based on PSMA-PET detected disease after maximal systemic response. The primary endpoint is the rate of FFS at 1 year. Patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.
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 seems likely that you can continue your existing treatment, as the trial involves patients who have already achieved a stable response to their current therapy.
What data supports the effectiveness of the treatment SABR for metastatic prostate cancer?
Research suggests that SABR, a precise form of radiotherapy, may improve survival and delay further spread of cancer in patients with certain types of metastatic prostate cancer. Initial results also indicate that SABR is promising for localized prostate cancer, though more long-term data is needed.
12345Is Stereotactic Ablative Body Radiotherapy (SABR) safe for humans?
Stereotactic Ablative Body Radiotherapy (SABR) has been used in treating prostate cancer, and studies suggest it is generally safe, though concerns about treatment-related side effects and quality of life impacts remain.
26789How does the treatment SABR differ from other treatments for metastatic prostate cancer?
Stereotactic ablative body radiotherapy (SABR) is unique because it delivers high doses of radiation precisely to cancerous areas in a few sessions, minimizing damage to surrounding healthy tissue. This approach is particularly beneficial for treating small, localized areas of cancer spread, known as oligometastases, and can improve survival and delay further cancer spread compared to standard treatments.
13101112Eligibility Criteria
This trial is for men with metastatic prostate cancer who are part of the PERa registry and have shown the best possible response to standard treatments, as seen by stable PSA levels. They should be able to perform daily activities (ECOG 0-2) and have a PSA greater than 0.2 ng/mL. Only those with 1-5 areas of cancer detectable on PSMA-PET scans that can be targeted by SABR will qualify.Inclusion Criteria
I have 1-5 areas of cancer visible on a PSMA-PET scan that can be treated with targeted radiation.
PSA > 0.2 ng/mL
I can take care of myself and perform daily activities.
+2 more
Exclusion Criteria
Not applicable.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive experimental SABR based on PSMA-PET detected disease after maximal systemic response
Duration not specified
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Long-term follow-up
Participants are monitored for long-term outcomes such as toxicity and progression
5 years
Participant Groups
The ANCHOR-Prostate trial is testing whether adding a type of precise radiation therapy called SABR (Stereotactic Ablative Radiotherapy) after maximum response from usual drug treatments can help control prostate cancer better. The main goal is to see if patients remain free from disease progression one year after treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: SABR consolidationExperimental Treatment1 Intervention
Group II: Control - no SABR consolidationActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CRCHUMMontreal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
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.
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.
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 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.
Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT). [2021]Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
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.
Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer. [2022]Stereotactic body radiation therapy (SBRT) for localized prostate cancer involves high-dose-per-fraction radiation treatments. Its use is increasing, but concerns remain about treatment-related toxicity. The authors assessed the incidence and predictors of a global decline in health-related quality of life (HRQOL) after prostate SBRT.
Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]The safety and efficacy of stereotactic body radiotherapy (SBRT) in localised prostate cancer are now established through phase III randomised trials. Its utility in node-positive prostate cancer is restricted due to a lack of controlled studies specifically addressing this subgroup. Herein we report the safety and efficacy of SBRT in this subgroup.
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 (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.
Prostate-specific membrane antigen-positron emission tomography/computed tomography (PSMA-PET/CT)-guided stereotactic ablative body radiotherapy for oligometastatic prostate cancer: a single-institution experience and review of the published literature. [2020]To report the outcomes of stereotactic ablative body radiotherapy (SABR) in men with oligometastatic prostate cancer (PCa) diagnosed on prostate-specific membrane antigen (PSMA)-positron emission tomography/computed tomography (PET/CT), based on a single-institution experience and the published literature.