Comparing Shorter vs. Standard Radiation for High-Risk Prostate Cancer (High Five)

https://www.facingourrisk.org/research-clinical-trials/study/397 /comparing-shorter-vs-standard-radiation-for-high-risk-prostate-cancer

Clinicaltrials.gov identifier:
NCT05946213 (https://clinicaltrials.gov/show/NCT05946213)

Treatment
Phase 3 treatment study for high-risk prostate cancer to compare two different radiation therapy schedules

Study Contact Information:

Call 877-632-6789 or email [email protected]

About the Study

This study is for people with high-risk prostate cancer. It will be testing if radiation delivered in 5 treatments over 2 weeks using a higher dose per treatment can prevent the cancer from coming back at least as well as the usual radiation treatment delivered in 20 to 45 treatments over 4 to 9 weeks.

What the Study Involves

Participants are randomly assigned to one of two groups:

Group 1 (shorter treatment):
Receive a type of radiation called SBRT, given in 5 treatment sessions over about 2 weeks
Group 2 (standard treatment):
Receive standard radiation therapy, given in 20 to 45 treatment sessions over about 4 to 9 weeks

Before and during treatment, participants will have imaging tests (such as CT, MRI, PET/CT, or bone scans) to monitor their cancer. Some participants may also provide blood and urine samples.

After treatment, participants will be followed every 6 months for up to 5 years to monitor their cancer, side effects, and quality of life.

This Study is Open To:

Adults (age 18 and older) who:

Have prostate cancer confirmed by biopsy
Have high-risk prostate cancer, such as:
- A high PSA level (greater than 20)
- A high Gleason score (8–10)
- Cancer that has spread to nearby lymph nodes
Do not have cancer that has spread to distant parts of the body
Are well enough to carry out daily activities
Have not had prior prostate treatments, such as:
- Surgery to remove the prostate
- Radiation to the prostate area
- Targeted treatments (such as HIFU, cryotherapy, or laser therapy)
May have started hormone therapy within the past 6 months
Are able to undergo MRI scans

This Study is Not Open To:

People who:

Have cancer that has spread to distant parts of the body
Have had prior prostate surgery or radiation
Have had targeted prostate treatments (such as HIFU or cryotherapy)
Started hormone therapy more than 6 months ago
Cannot safely undergo MRI scans
Are unable to meet the study’s health or activity requirements

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.