← Back to Search

Proton Beam Therapy

Radiation + Androgen Suppression for Prostate Cancer

Phase 3

Recruiting

Led By Carlos Vargas, MD

Research Sponsored by Proton Collaborative Group

Eligibility Criteria Checklist

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

Must have

Patients must be at least 18 years old

Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended

Must not have

Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery

Previous pelvic radiation for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after the initial 100 patients have had a median follow up of at least three years and then every year.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of two treatments for prostate cancer.

Who is the study for?

Men with intermediate-risk prostate cancer who have not had previous prostate surgery, androgen suppression therapy, or pelvic radiation. They must be in good physical condition (ECOG 0-1), have a Gleason Score of 7, PSA levels between 10-20 ng/ml, T stage T2b-T2c, and no major medical issues that could affect the study.

What is being tested?

The trial is testing hypofraction proton therapy alone versus proton therapy combined with androgen suppression. Participants will receive either just the radiation treatment or both treatments to see which is more effective at treating localized prostate cancer.

What are the potential side effects?

Potential side effects include skin reactions from radiation like redness or irritation, fatigue due to treatment stress on the body, urinary issues such as increased frequency or discomfort during urination, bowel changes including diarrhea or rectal discomfort.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

My prostate cancer has a Gleason score between 2 and 7, based on more than 6 biopsy samples.

Select...

My breast cancer is in an early stage and has not spread to lymph nodes or other parts of my body.

Select...

My prostate is smaller than 55cc before starting active surveillance.

Select...

My prostate cancer is at intermediate risk of coming back, confirmed by tests within the last year.

Exclusion Criteria

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

Select...

I have had surgery for prostate cancer, including removal, heating, or freezing of the prostate.

Select...

I have had radiation therapy for prostate cancer in the pelvic area.

Select...

I have had hormone therapy for prostate cancer.

Select...

I have had chemotherapy for prostate cancer before.

Select...

I have had a blockage in my urethra that needed stretching.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after the initial 100 patients have had a median follow up of at least three years and then every year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after the initial 100 patients have had a median follow up of at least three years and then every year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after the initial 100 patients have had a median follow up of at least three years and then every year. for reporting.