Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)

Prostate Cancer Clinical Trial

Official title:

A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03269422
• Other study ID #: 17-407
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 28, 2017
• Est. completion date: August 28, 2024

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: August 28, 2024
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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
• Additionally, patients will be required to meet the following criteria:
• Age >18
• KPS > 80
• Prostate size < 60cc
• Presence of a prostatic lesion with maximum dimension of >/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
• International Prostrate Symptom Score < 15
• Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria

Exclusion Criteria:

• Prior androgen deprivation therapy for prostate cancer
• Evidence of metastatic disease on bone scan or MRI/CT
• MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
• Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
• Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
• Contra-indications to receiving gadolinium contrast
• KPS < 80
• Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.
• Prior history of transurethral resection of the prostate
• Prior history of chronic prostatitis
• Prior history of urethral stricture
• Prior history of pelvic irradiation
• History of inflammatory bowel disease
• Unable to give informed consent
• Unable to complete quality of life questionnaires
• Abnormal complete blood count. Any of the following
• Platelet count less than 75,000/ml
• Hb level less than 10 gm/dl
• WBC less than 3.5/ml
• Abnormal renal function tests (creatinine > 1.5)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• MR-based image-guided, intensity-modulated radiotherapy
Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent only and follow up)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent and follow up)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity	Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity	36 months

External Links

•   Memorial Sloan Kettering Cancer Center