Hypofractionated Radiotherapy for Prostate Cancer
(HEAT Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must be taking: Androgen deprivation
Disqualifiers: T3b disease, N1 or M1, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing if giving higher doses of radiation in fewer treatments is as effective as the standard approach for treating prostate cancer. Delivering higher doses per treatment has been shown to be potentially more effective and efficient compared to the traditional method.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anticoagulants, you must be cleared by your primary care physician or cardiologist to have gold fiducial markers placed in the prostate.
What data supports the effectiveness of the treatment Hypofractionated Radiotherapy for Prostate Cancer?
Research shows that hypofractionated radiotherapy, including stereotactic body radiotherapy (SBRT), is effective for treating prostate cancer. Studies report positive outcomes for both high-risk and low-risk prostate cancer patients, with SBRT providing a high dose of radiation in fewer sessions, which can improve treatment results without increasing side effects.
12345Is hypofractionated radiotherapy safe for prostate cancer treatment?
Research shows that hypofractionated radiotherapy, including stereotactic body radiotherapy (SBRT), is generally safe for treating prostate cancer, with studies reporting good short-term safety outcomes. However, more long-term studies are needed to confirm these findings.
16789How is hypofractionated radiotherapy for prostate cancer different from other treatments?
Hypofractionated radiotherapy for prostate cancer, including stereotactic body radiotherapy (SBRT), uses fewer but larger doses of radiation, which can be more effective at killing cancer cells and is more convenient for patients compared to traditional radiotherapy. This approach takes advantage of the prostate cancer cells' unique sensitivity to radiation, potentially offering a more efficient and cost-effective treatment option.
1461011Eligibility Criteria
Men aged 35-85 with prostate cancer, Gleason score 2-7, and PSA <20 ng/ml can join this trial. They must have a prostate size ≤80 cc, no prior major prostate treatments or pelvic radiation, and no chemotherapy for any cancer in the last 5 years. Men with low to intermediate risk of cancer spread based on specific clinical criteria are eligible.Inclusion Criteria
My prostate cancer was confirmed through a tissue examination.
My prostate cancer has a low to medium grade.
My PSA level is below 20 ng/ml, measured within the last 3 months.
+11 more
Exclusion Criteria
Implanted hardware which limits treatment planning or delivery
I have not had chemotherapy in the last 5 years.
I have used hormone therapy for prostate cancer for more than 2 months.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Accelerated Hypofractionation Radiotherapy (AHRT) over 2 weeks or Extended Hypofractionation Radiotherapy (EHRT) over 6 weeks
2-6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of HRQOL and overall survival
Up to 5.25 years
Participant Groups
The trial is testing two different radiotherapy schedules for treating prostate cancer: one delivers a total dose of radiation over fewer sessions (accelerated) while the other spreads it out over more sessions (extended). The goal is to see if the accelerated method is as effective as the standard extended treatment after two years.
2Treatment groups
Experimental Treatment
Group I: Extended Hypofractionation Radiotherapy (EHRT) GroupExperimental Treatment1 Intervention
Participants in this group will receive the EHRT intervention over a period of 6 weeks.
Group II: Accelerated Hypofractionation Radiotherapy (AHRT) GroupExperimental Treatment1 Intervention
Participants in this group will receive the AHRT intervention over a period of 2 weeks.
Accelerated Hypofractionation Radiotherapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Accelerated Hypofractionation Radiotherapy for:
- Prostate cancer
🇪🇺 Approved in European Union as Hypofractionated Radiation Therapy for:
- Prostate cancer
🇨🇦 Approved in Canada as Stereotactic Body Radiotherapy (SBRT) for:
- Prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
Jay L. Friedland MD Prostate Cancer Research FundCollaborator
References
The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]The rationale for hypofractionated radiotherapy in the treatment of prostate cancer is based on the modern understanding of radiobiology and advances in stereotactic body radiotherapy (SBRT) techniques. Whole-pelvis irradiation combined with SBRT boost for high-risk prostate cancer might escalate biologically effective dose without increasing toxicity. Here, we report our 4-year results of SBRT boost for high-risk localized prostate cancer.
Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. [2021]Hypofractionated stereotactic body radiation therapy (SBRT) has been advanced as monotherapy for low-risk prostate cancer. We examined the dose distributions and early clinical outcomes using this modality for the treatment of intermediate-risk prostate cancer.
Prostate stereotactic body radiotherapy—first UK experience. [2022]Stereotactic body radiotherapy (SBRT) combines image-guided radiotherapy with hypofractionation, both of which will probably result in improvements in patient outcomes in prostate cancer. Most clinical experience with this technique resides in North America. Here we present the first UK cohort to receive SBRT for prostate cancer.
Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. [2022]Hypofractionated, stereotactic body radiotherapy (SBRT) is an emerging treatment approach for prostate cancer. We present the outcomes for low-risk prostate cancer patients with a median follow-up of 5 years after SBRT.
Stereotactic radiotherapy of the prostate: fractionation and utilization in the United States. [2020]To analyze the utilization and fractionation of extreme hypofractionation via stereotactic body radiotherapy (SBRT) in the treatment of prostate cancer.
Hypofractionated radiotherapy for organ-confined prostate cancer: is less more? [2018]Moderate hypofractionation of radiotherapy is widely considered a viable alternative to conventional fractionation for the treatment of patients with organ-confined prostate cancer, but stereotactic body radiotherapy (SBRT) is rapidly emerging as a novel treatment modality for this disease. Advances in treatment planning, image guidance, target position reproducibility and on-line tracking, coupled with a compelling radiobiological rationale, have promoted SBRT as a safe and effective treatment. Dose escalation to the tumour tissue through a decreased number of radiation fractions improves patient comfort and convenience, as well as treatment cost-effectiveness, compared with conventional radiotherapy regimens. Several clinical trials have investigated moderate and extreme hypofractionation of radiotherapy in patients with prostate cancer. Evidence is accumulating which suggests that the use of moderately hypofractionated radiotherapy can be recommended regardless of cancer risk group. Regimens of extremely hypofractionated radiotherapy have shown very good short-term efficacy and safety outcomes, but appropriately designed trials with extended follow-up monitoring are required to confirm long-term outcomes.
Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. [2022]Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented.
Acute side effects after definitive stereotactic body radiation therapy (SBRT) for patients with clinically localized or locally advanced prostate cancer: a single institution prospective study. [2022]The aim of the study was to evaluate acute side effects after extremely hypofractionated intensity-modulated radiotherapy (IMRT) with stereotactic body radiation therapy (SBRT) for definitive treatment of prostate cancer patients.
Stereotactic body radiation therapy for the primary treatment of localized prostate cancer. [2021]The low alpha/beta ratio of prostate cancer suggests that hypofractionated schemes of dose-escalated radiotherapy should be advantageous. We report our experience using stereotactic body radiation therapy (SBRT) for the primary treatment of prostate cancer to assess efficacy and toxicity.
[Ultra-hypofractionated radiotherapy for the treatment of localized prostate cancer: Results, limits and prospects]. [2021]Still an emerging approach a few years ago, stereotactic body radiation therapy (SBRT) has ranked as a valid option for the treatment of localized prostate cancer. Inherent properties of prostatic adenocarcinoma (low α/β) make it the perfect candidate. We propose a critical review of the literature trying to put results into perspective to identify their strengths, limits and axes of development. Technically sophisticated, the stereotactic irradiation of the prostate is well tolerated. Despite the fact that median follow-up of published data is still limited, ultra-hypofractionated radiotherapy seems very efficient for the treatment of low and intermediate risk prostate cancers. Data seem satisfying for high-risk cancers as well. New developments are being studied with a main interest in treatment intensification for unfavorable intermediate risk and high-risk cancers. Advantage is taken of the sharp dose gradient of stereotactic radiotherapy to offer safe reirradiation to patients with local recurrence in a previously irradiated area.
Stereotactic body radiotherapy for prostate cancer: treatment approaches and clinical outcomes. [2020]Extreme hypofractionation may be a radiobiologically sound strategy against prostate cancer cells with presumed low radiosensitivity (α) and high repair capacity (β) to small treatment fractions. In this case, large doses per fraction may be more effective in the tumor cell killing. Hence, the fractionation sensitivity differential (tumor/normal tissue) favors the use of hypofractionated radiotherapy (RT) as tumor α/β values are lower than the values considered for late normal-tissue morbidity. High-dose rate brachytherapy (HDR-BT) and stereotactic body RT (SBRT) are competing extreme hypofractionated treatment methods aiming to efficiently escalate the dose against prostate cancer. Focal treatment strategies to the dominant and non-dominant tumor nodules inside the prostate have been considered with both treatment approaches.The present status of SBRT for prostate cancer is presented as well as a comparative summary of the existing studies on partial prostate boost irradiation either with HDR-BT or SBRT. Extreme hypofractionation (i.e., >6 Gy/fraction) still deserves investigation in prospective trials provided that the precaution is taken to assure an homogeneous tumor dose distribution, a short overall treament time (