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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MR-based image-guided, intensity-modulated radiotherapy

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2026
Study completion: 2026
First posted: Aug 31, 2017
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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