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

Phase 1

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT03269422
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-28
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Status Verified: 2024-09
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-08-28
• Study Completion: 2025-08-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent only and follow up); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, 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 Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Consent and follow up); 🇺🇸 Uniondale, New York, United States