Hypofractionated Radiotherapy for Prostate Cancer

(HEAT Trial)

Recruiting at 2 trial locations

Overseen By Jacqueline Rodriguez Amado

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Androgen deprivation

Disqualifiers: T3b disease, N1 or M1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2-6 weeks

456 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 4 6 10 11}

Research Team

Alan Pollack, MD

Principal Investigator

University of Miami

Matthew Abramowitz, MD

Principal Investigator

University of Miami

Eligibility 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.

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.

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

Treatment Details

Interventions

• Accelerated Hypofractionation Radiotherapy
• Extended Hypofractionation Radiotherapy

Trial Overview 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.

Participant Groups

Group I: Extended Hypofractionation Radiotherapy (EHRT) Group Experimental Treatment 1 Intervention

Participants in this group will receive the EHRT intervention over a period of 6 weeks.

Group II: Accelerated Hypofractionation Radiotherapy (AHRT) Group Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Jay L. Friedland MD Prostate Cancer Research Fund

Collaborator

Trials

1

Recruited

460+

Findings from Research

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

In a study of 41 hormone-naïve intermediate-risk prostate cancer patients treated with hypofractionated SBRT, the treatment resulted in a significant decrease in PSA levels from an average of 7.67 ng/mL to 0.64 ng/mL at a median follow-up of 21 months, indicating effective early clinical outcomes.

No severe toxicities (Grade 3 or 4) were observed, and while there was a temporary decline in urinary and bowel quality of life scores post-treatment, they returned to baseline levels, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. Ju, AW., Wang, H., Oermann, EK., et al.[2021]

In a study involving 51 prostate cancer patients treated with stereotactic body radiotherapy (SBRT), the treatment showed promising outcomes with manageable toxicity levels, as no patients experienced severe (grade 3+) side effects during the initial follow-up period.

The median follow-up of 14.5 months revealed a low prostate-specific antigen level of 1.3 ng/ml at 13-18 months post-treatment, indicating effective disease control in this cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. Tree, AC., Ostler, P., Hoskin, P., et al.[2022]

In a study of 41 low-risk prostate cancer patients treated with hypofractionated stereotactic body radiotherapy (SBRT), the 5-year biochemical progression-free survival rate was an impressive 93%, indicating strong efficacy of this treatment.

The treatment was well-tolerated, with acute side effects resolving within 1-3 months and no severe (grade 4) toxicities reported, highlighting the safety of SBRT for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. Freeman, DE., King, CR.[2022]

A study of 299,186 men with localized prostate cancer revealed that the use of stereotactic body radiotherapy (SBRT) as a primary treatment increased from 0.1% in 2004 to 4.0% in 2012, indicating a growing acceptance of this treatment method.

The most common treatment regimen for SBRT was 725 cGy delivered in five fractions, used by 49.6% of patients, suggesting that this dosing pattern is becoming the standard approach as more long-term safety and efficacy data becomes available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy of the prostate: fractionation and utilization in the United States. P Weiner, J., Schwartz, D., Shao, M., et al.[2020]

Stereotactic body radiotherapy (SBRT) is emerging as a safe and effective treatment for organ-confined prostate cancer, offering improved patient comfort and cost-effectiveness through fewer radiation fractions.

Moderate hypofractionation of radiotherapy is recommended for all cancer risk groups, while extremely hypofractionated regimens show promising short-term efficacy and safety, though more long-term studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for organ-confined prostate cancer: is less more? Arcangeli, S., Greco, C.[2018]

In a study of 67 patients with low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), significant late bladder and rectal toxicities were infrequent, with no grade 4 toxicities reported and only 3% experiencing grade 3 bladder toxicity.

The 4-year PSA relapse-free survival rate was 94%, indicating that SBRT is effective in controlling prostate cancer and should be considered as a treatment option alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. King, CR., Brooks, JD., Gill, H., et al.[2022]

In a study of 205 prostate cancer patients treated with stereotactic body radiation therapy (SBRT), 99% completed the treatment without severe acute side effects, indicating that this method is safe and well-tolerated.

The most common acute side effects were mild to moderate, with 50.7% experiencing grade II genitourinary issues and 31.7% experiencing grade I gastrointestinal issues, but no patients had severe (grade ≥ 4) toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jorgo, K., Polgar, C., Stelczer, G., et al.[2022]

Stereotactic body radiation therapy (SBRT) using the CyberKnife system showed high efficacy in treating localized prostate cancer, with a 3-year freedom from biochemical failure of 100% for low-risk and 95% for intermediate-risk patients, and a significant dose response in high-risk patients.

The treatment demonstrated acceptable toxicity levels, with only 4% of patients experiencing acute grade III genitourinary toxicities, and 83% of hormone-naïve patients maintaining their potency post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for the primary treatment of localized prostate cancer. Oliai, C., Lanciano, R., Sprandio, B., et al.[2021]

Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment option for localized prostate cancer, particularly for low and intermediate risk cases, with promising results for high-risk cancers as well.

The technique's sharp dose gradient allows for safe reirradiation in patients with local recurrence, highlighting its potential for treatment intensification in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultra-hypofractionated radiotherapy for the treatment of localized prostate cancer: Results, limits and prospects]. Graff, P., Crehange, G.[2021]

Extreme hypofractionation, which involves delivering large doses of radiation in fewer sessions, may be particularly effective for prostate cancer due to the tumor's low sensitivity to radiation and high ability to repair damage.

Both high-dose rate brachytherapy (HDR-BT) and stereotactic body radiotherapy (SBRT) are promising methods for this approach, but further research is needed to ensure effective dose distribution and minimize treatment duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: treatment approaches and clinical outcomes. Miralbell, R.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy of the prostate: fractionation and utilization in the United States. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for organ-confined prostate cancer: is less more? [2018]

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

Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. [2022]

8. Poland pubmed.ncbi.nlm.nih.gov

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]

9. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for the primary treatment of localized prostate cancer. [2021]

10. France pubmed.ncbi.nlm.nih.gov

[Ultra-hypofractionated radiotherapy for the treatment of localized prostate cancer: Results, limits and prospects]. [2021]

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

Stereotactic body radiotherapy for prostate cancer: treatment approaches and clinical outcomes. [2020]