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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-04

Study Completion Date

2026-08-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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SBRT

Eligibility Criteria

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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 or
* 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 or prostate 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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No