What side effects are associated with this type of intervention?

Accelerated hypofractionation radiotherapy, which involves delivering higher doses of radiation in fewer sessions, can lead to side effects such as urinary symptoms (e.g., frequency, urgency, and discomfort), bowel symptoms (e.g., diarrhea, rectal bleeding, and pain), and fatigue. Other common treatments for prostate cancer, such as androgen deprivation therapy (ADT), can cause hot flashes, decreased libido, osteoporosis, and metabolic changes. Chemotherapy, particularly with drugs like docetaxel, may result in side effects including nausea, hair loss, fatigue, and an increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including various forms of radiotherapy and systemic therapies. One notable approval is for lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy for PSMA-positive metastatic castration-resistant prostate cancer (CRPC). Additionally, androgen receptor signaling inhibitors like enzalutamide and apalutamide, as well as chemotherapeutic agents such as docetaxel, have been approved. While specific FDA approvals for hypofractionated radiotherapy in prostate cancer are not detailed, the general trend towards more efficient and targeted treatments is evident in these approvals.

What other types of research exist?

Promising novel alternatives to Accelerated Hypofractionation Radiotherapy for prostate cancer patients include Bipolar Androgen Therapy (BAT), which has shown potential in restoring sensitivity to treatments like abiraterone and enzalutamide, and the combination of Androgen Deprivation Therapy (ADT) with newer agents such as darolutamide or abiraterone for high-risk/high-volume disease. Additionally, the use of immune checkpoint inhibitors like pembrolizumab for patients with specific genetic markers (dMMR or high TMB) is also emerging as a viable option.

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Radiation Therapy

Hypofractionated Radiotherapy for Prostate Cancer (HEAT Trial)

Q: What is the mechanism of action of this treatment?

Prostate cancer treatments primarily include radiation therapy, androgen deprivation therapy (ADT), and immunotherapy. Radiation therapy, such as hypofractionation, works by delivering high doses of radiation to the prostate cancer cells in fewer sessions, causing DNA damage that leads to cell death. This approach can be more convenient and potentially more effective for patients. ADT reduces the levels of androgens (male hormones) that prostate cancer cells rely on for growth, thereby slowing disease progression. Immunotherapy, like sipuleucel-T, stimulates the patient's immune system to target and destroy prostate cancer cells. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, balancing efficacy, convenience, and potential side effects.

N/A

Recruiting

Led By Alan Pollack, MD, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven prostate adenocarcinoma

Gleason score 2-7 (reviewed by reference lab at UM)

Must not have

Patient has stage N1 or M1 disease

Zubrod performance status 2 or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.25 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from both types of radiotherapy may include skin irritation in treated areas, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer was confirmed through a tissue examination.

Select...

My prostate cancer has a low to medium grade.

Select...

I can have gold markers placed in my prostate.

Select...

I am between 35 and 85 years old.

Select...

My cancer is in an early stage and has not spread to distant parts of my body.

Select...

My prostate is 80 cc or smaller.

Select...

I can carry out all my usual activities without help.

Select...

I have not had my prostate completely removed or frozen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to nearby lymph nodes or other parts of my body.

Select...

I have some trouble doing my daily activities due to my health.

Select...

I have had my entire prostate removed.

Select...

I do not have prostate cancer.

Select...

My cancer is at a stage where it has grown significantly but not spread to distant organs.

Select...

I have not had chemotherapy in the last 5 years.

Select...

I cannot have gold markers placed in my prostate.

Select...

I am younger than 35 or older than 85 years old.

Select...

My prostate is larger than 80 cc.

Select...

I have had radiation therapy to my prostate or lower pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.25 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5.25 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.25 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants achieving two-year failure.

Secondary study objectives

HRQOL as assessed by EPIC-SF-12 questionnaire

HRQOL as assessed by MAX-PC questionnaire

Incidence of late-occurring treatment related adverse events

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments primarily include radiation therapy, androgen deprivation therapy (ADT), and immunotherapy. Radiation therapy, such as hypofractionation, works by delivering high doses of radiation to the prostate cancer cells in fewer sessions, causing DNA damage that leads to cell death. This approach can be more convenient and potentially more effective for patients. ADT reduces the levels of androgens (male hormones) that prostate cancer cells rely on for growth, thereby slowing disease progression. Immunotherapy, like sipuleucel-T, stimulates the patient's immune system to target and destroy prostate cancer cells. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, balancing efficacy, convenience, and potential side effects.

Moderate hypofractionation for prostate cancer: A user's guide.Biological dose escalation and hypofractionation: what is there to be gained and how will it best be done?

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

949 Previous Clinical Trials

428,008 Total Patients Enrolled

19 Trials studying Prostate Cancer

3,841 Patients Enrolled for Prostate Cancer

Jay L. Friedland MD Prostate Cancer Research FundUNKNOWN

Alan Pollack, MD, PhDPrincipal InvestigatorUniversity of Miami

5 Previous Clinical Trials

2,143 Total Patients Enrolled

5 Trials studying Prostate Cancer

2,143 Patients Enrolled for Prostate Cancer

Media Library

$Accelerated Hypofractionation Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01794403 — N/A$

$Prostate Cancer Research Study Groups: Accelerated Hypofractionation Radiotherapy (AHRT) Group, Extended Hypofractionation Radiotherapy (EHRT) Group$