A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Radiation Therapy
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a boost dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:

‣ PSA 10-20 ng/ml or

⁃ Gleason score = 7 or

⁃ Clinical stage T2b/T2c or

• Additionally, patients will be required to meet all of the following criteria:

‣ Age ≥ 18

⁃ Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)

⁃ Prostate size ≤ 80 cc

⁃ Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus

⁃ MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted

⁃ International Prostate Symptom Score ≤ 15

⁃ Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Locations
United States
New Jersey
Victoria Brennan
RECRUITING
Basking Ridge
Victoria Brennan
RECRUITING
Middletown
Victoria Brennan
RECRUITING
Montvale
New York
Victoria Brennan
RECRUITING
Commack
Victoria Brennan
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Victoria Brennan
RECRUITING
Uniondale
Contact Information
Primary
Victoria Brennan, MBBCH BAO
brennanv@mskcc.org
212-639-8904
Backup
Michael Zelefsky, MD
zelefskm@MSKCC.ORG
212-639-6802
Time Frame
Start Date: 2021-08-04
Estimated Completion Date: 2026-08-04
Participants
Target number of participants: 91
Treatments
Experimental: Prostate cancer patients
Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:~* PSA 10-20 ng/ml or~* Gleason score = 7~* Clinical stage T2b/T2c
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov