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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2026-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MR Image Guided, Intensity-Modulated Radiotherapy

Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.

Group Type EXPERIMENTAL

MR-based image-guided, intensity-modulated radiotherapy

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No