A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04997018
Collaborator
(none)
91
Enrollment
7
Locations
1
Arm
24
Anticipated Duration (Months)
13
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: Radiation Therapy
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
91 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 4, 2021
Anticipated Primary Completion Date :
Aug 4, 2023
Anticipated Study Completion Date :
Aug 4, 2023

Arms and Interventions

ArmIntervention/Treatment
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

Radiation: Radiation Therapy
Patients enrolled in this study will undergo ultra-hypofractionated radiation utilizing MR guided, daily online adaptive planning. 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 the pretreatment diagnostic T2 MRI imaging. In the setting of two similarly-sized "dominant" lesions, both will be boosted.
Other Names:
  • SBRT
  • Outcome Measures

    Primary Outcome Measures

    1. Comparison of pretreatment biopsy with post-treatment biopsy [24 months]

      The primary outcome of efficacy will be studied using post -treatment biopsies. To demonstrate efficacy of dose escalation to the DIL, the investigators aim to reduce the positive post-treatment biopsy rates at 24 months for intermediate risk disease from 20% to 10%.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    • Clinical stage T2b/T2c

    • 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

    Exclusion Criteria:
    Patient will be excluded if they meet any one of the following criteria:
    • Gleason score >7

    • PSA >20

    • Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE

    • MRI findings: >2 disease foci identifiable

    • 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; inability to lie flat for the duration of the study; etc.

    • 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 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, including 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

    Locations

    SiteCityStateCountryPostal Code
    1Victoria BrennanBasking RidgeNew JerseyUnited States07920
    2Victoria BrennanMiddletownNew JerseyUnited States07748
    3Victoria BrennanMontvaleNew JerseyUnited States07645
    4Victoria BrennanCommackNew YorkUnited States11725
    5Victoria BrennanHarrisonNew YorkUnited States10604
    6Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew YorkUnited States10065
    7Victoria BrennanUniondaleNew YorkUnited States11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Victoria Brennan, MBBCH BAO, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04997018
    Other Study ID Numbers:
    • 21-308
    First Posted:
    Aug 9, 2021
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021