MRI-Guided Prostate Boosts for Prostate Cancer

(BLaStM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Alan Pollack, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to learn about: 1) improving control of prostate cancer using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in addition to the standard radiation treatment to the rest of the prostate; 2) preserving quality of life by reducing dose to the nearby organs at risk around the prostate; and 3) establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results at 2-2.5 years after treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are on androgen deprivation therapy (ADT), there are specific guidelines you must follow. Please discuss with your doctor for more details.

What data supports the idea that MRI-Guided Prostate Boosts for Prostate Cancer is an effective treatment?

The available research shows that MRI-Guided Prostate Boosts, also known as Stereotactic Ablative Radiotherapy (SABR), is effective for treating prostate cancer, especially for low- and intermediate-risk patients. Studies indicate that SABR can deliver high doses of radiation with precision, similar to brachytherapy, but with fewer side effects. It is also less costly and uses fewer resources compared to other radiation techniques. While SABR is promising for high-risk patients, more data is needed before it can be widely recommended for them outside of clinical trials. Overall, SABR is a promising treatment option for prostate cancer, offering similar effectiveness to traditional methods with potential benefits in cost and side effects. ^{1 2 3 4 5}

What safety data exists for MRI-guided prostate boosts in prostate cancer treatment?

Stereotactic Ablative Radiotherapy (SABR) and its variants, such as Stereotactic Body Radiation Therapy (SBRT), have been studied for prostate cancer treatment. For low- and intermediate-risk patients, SABR has been compared to other radiotherapy methods in large randomized studies, showing it to be feasible and well-tolerated with careful planning. However, for high-risk patients, there is insufficient data to recommend its use outside clinical trials. Studies have shown that SABR is cost-effective and increases system capacity, with promising safety and efficacy results, especially when using advanced systems like CyberKnife. Long-term safety data at higher dose levels is still limited, but SABR is becoming a standard of care for low and intermediate-risk prostate cancer based on positive outcomes from various studies. ^{1 5 6 7 8}

Is the treatment HEIGHT RT, LEAD RT a promising treatment for prostate cancer?

Yes, HEIGHT RT, LEAD RT, which includes methods like Stereotactic Body Radiation Therapy (SBRT), is promising for treating prostate cancer. Studies show that using MRI guidance with this treatment can lead to better outcomes for patients. It helps doctors target the cancer more precisely, which can improve the effectiveness of the treatment and potentially reduce side effects. ^{9 10 11 12 13}

Eligibility Criteria

Men aged 35-85 with confirmed prostate cancer (adenocarcinoma), T1-T3 stage, Gleason score 6-10, and PSA ≤100 ng/mL. No metastasis or previous radical prostate surgery/radiotherapy. Androgen deprivation therapy is allowed if decided before joining. Participants must be able to consent and willing to complete quality of life assessments.

Inclusion Criteria

My prostate cancer has a Gleason score between 6 and 10.

Suspicious peripheral zone or central gland lesion on MP-MRI

My prostate cancer is confirmed by biopsy.

Exclusion Criteria

I have a history of disorders related to lymphocyte proliferation.

I have a history of cancer.

I do not have any active cancer except for non-spreading skin cancer or early chronic lymphocytic leukemia.

Treatment Details

Interventions

• HEIGHT RT (Proton Beam Therapy)
• LEAD RT (Proton Beam Therapy)

Trial Overview The study tests adding a high dose radiation treatment targeting MRI-defined high-risk tumor areas in the prostate, on top of standard radiation therapy, aiming to control cancer while sparing nearby organs from excess radiation.

Participant Groups

Group I: LEAD RT Group Experimental Treatment 1 Intervention

Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Group II: HEIGHT RT Group Experimental Treatment 1 Intervention

Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

HEIGHT RT is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

🇺🇸 Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

🇨🇦 Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

Who Is Running the Clinical Trial?

University of Miami Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

Gantry-Based 5-Fraction Elective Nodal Irradiation in Unfavorable-Risk Prostate Cancer: Outcomes From 2 Prospective Studies Comparing SABR Boost With MR Dose-Painted HDR Brachytherapy Boost. [2022] Guidelines from the American Society of Clinical Oncology and Cancer Care Ontario recommend brachytherapy boost for patients with intermediate-risk or high-risk prostate cancer. SABR is an emerging technique for prostate cancer, but its use in high-risk disease is limited. Efficacy, toxic effects, and quality of life (QoL) were compared in patients treated on 2 prospective protocols that used SABR boost or magnetic resonance-guided high-dose-rate brachytherapy (HDR-BT) boost with 6 to 18 months of androgen deprivation therapy (ADT).

3. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023] Prostate is the most common non-cutaneous cancer diagnosed among men in North America. Fortunately most prostate cancers are screen detected and non-metastatic on diagnosis. Treatment options for men with localized prostate cancer include surgery ± postoperative radiation or radiation ± androgen deprivation therapy (ADT). Brachytherapy ± external beam radiation treatment (EBRT) appears to have superior long-term disease control over EBRT alone likely because of higher biologic effective dose delivered. Stereotactic ablative body radiation (SABR) is a novel, non-invasive, high-precision EBRT technique that allows safe delivery of biologic doses similar to brachytherapy with similar or lower side effects [measured using toxicity or quality of life (QOL) scales]. Efficacy for SABR appears to be similar to brachytherapy including positive biopsy rates 2-3 years post treatment, biochemical failure (BF) rates out to 10-year and incidence of metastases. SABR dose escalation reduces biopsy positivity and prostate-specific antigen (PSA) nadirs but increases genitourinary (GU) and gastrointestinal (GI) toxicity-no effect on BF has been realized yet. The overall treatment time (OTT) varies in many protocols. Phase 2 randomized data shows that QOL is better in the acute setting with a weekly course of treatment compared to an every other day treatment regimen with no difference in late setting. Follow-up data are immature and likely underpowered to determine efficacy differences. SABR is cheaper and uses less resource than any other radiation technique. Given the healthcare resource challenges (including financial resources), SABR would be a welcomed addition if studies show non-inferiority to other radiation techniques. For patients with de novo or metastatic disease on relapse, there is much enthusiasm regarding the use of SABR in the setting of oligometastatic prostate cancer. SABR appears to be feasible to deliver, well tolerated and may delay the next line of therapy. However, until adequately powered randomized studies confirm a benefit, such an approach cannot be considered standard of care treatment at this time. Enrollment of eligible prostate cancer patients onto SABR clinical trials should be encouraged.

4. Ireland pubmed.ncbi.nlm.nih.gov

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.

5. United States pubmed.ncbi.nlm.nih.gov

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.

6. United States pubmed.ncbi.nlm.nih.gov

Treatment outcomes of postoperative ultra-hypofractionated stereotactic body radiotherapy in prostate cancer. [2023] This study aimed to evaluate the safety and efficacy of ultra-hypofractionated stereotactic body radiation therapy (SBRT) to prostate bed.

7. Switzerland pubmed.ncbi.nlm.nih.gov

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.

8. Switzerland pubmed.ncbi.nlm.nih.gov

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.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Outcome of the first 200 patients with prostate cancer treated with MRI-Linac at Assuta MC. [2023] We present our experience with MR-guided stereotactic body radiotherapy (SBRT) for 200 consecutive patients with prostate cancer with minimum 3-month follow-up.

10. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: preliminary results of outcome and toxicity. [2022] Using moderate or ultra-hypofractionation, which is also known as stereotactic body radiotherapy (SBRT) for treatment of localized prostate cancer patients has been increased. We present our preliminary results on the clinical utilization of MRI-guided adaptive radiotherapy (MRgRT) for prostate cancer patients with the workflow, dosimetric parameters, toxicities and prostate-specific antigen (PSA) response.

11. Switzerland pubmed.ncbi.nlm.nih.gov

1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes. [2021] Magnetic resonance-guided stereotactic body radiotherapy (MRgSBRT) offers the potential for achieving better prostate cancer (PC) treatment outcomes. This study reports the preliminary clinical results of 1.5T MRgSBRT in localized PC, based on both clinician-reported outcome measurement (CROM) and patient-reported outcome measurement (PROM).

12. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. [2023] Magnetic resonance imaging (MRI) guidance offers multiple theoretical advantages in the context of stereotactic body radiotherapy (SBRT) for prostate cancer. However, to our knowledge, these advantages have yet to be demonstrated in a randomized clinical trial.

13. Italy 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. [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.