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

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ClinicalTrials.gov Identifier: NCT03269422
Recruitment Status : Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: MR-based image-guided, intensity-modulated radiotherapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : August 28, 2021
Estimated Study Completion Date : August 28, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity [ Time Frame: 36 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269422


Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Consent and follow up)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03269422    
Other Study ID Numbers: 17-407
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
17-407
Intermediate Risk Prostate Cancer
DIL
Dominant Intra-Prostatic Lesion
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases