Clinical trial NCT03269422: Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: 17-407
Intermediate Risk Prostate Cancer
DIL
Dominant Intra-Prostatic Lesion
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and follow up)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Gorovets, MD
role: PRINCIPAL_INVESTIGATOR
References: