Trial Outcomes & Findings for MRI Guided SBRT for Localized Prostate Cancer (NCT NCT03778112)

Results Overview

Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

18 months

Results posted on

2025-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Negative mpMRI Prostate Scan SBRT to the whole prostate SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate	Positive mpMRI Prostate Scan IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions
Overall Study STARTED	4	50
Overall Study COMPLETED	4	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Negative mpMRI Prostate Scan n=4 Participants SBRT to the whole prostate SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate	Positive mpMRI Prostate Scan n=50 Participants IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=4 Participants	16 Participants n=50 Participants	18 Participants n=54 Participants
Age, Categorical >=65 years	2 Participants n=4 Participants	34 Participants n=50 Participants	36 Participants n=54 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=54 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	50 Participants n=50 Participants	54 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	50 participants n=50 Participants	54 participants n=54 Participants

PRIMARY outcome

Timeframe: 18 months

Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.

Outcome measures

Outcome measures
Measure	Negative mpMRI Prostate Scan n=4 Participants SBRT to the whole prostate SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate	Positive mpMRI Prostate Scan n=50 Participants IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions
Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity	4 participants	50 participants

SECONDARY outcome

Timeframe: 3 months

Adverse acute events are evaluated by the CTEP Active Version of the NCI CTCAE. The treatment-related attribution includes definitely, probably or possibly related to treatment. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of RT. For each cohort, we will evaluate the acute radiation therapy-related adverse events. Specifically, we are interested in the percentage of acute GI and GU Grade 3+ adverse events that occur in each arm, which is considered to be similar to the high RT dose arm of RTOG 0126 in terms of RT dose. For this arm, a reported 1% of patients experienced Grade 3+ GI/GU acute toxicity, with no patient experiencing Grade 4 or 5 toxicities. If either hypofractionated arm has an acceptable percentage, then that arm will be deemed to have an acceptable adverse event profile. We will report the percentage for each arm as well as the one-sided 97.5% confidence interval.

Outcome measures

Outcome measures
Measure	Negative mpMRI Prostate Scan n=4 Participants SBRT to the whole prostate SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate	Positive mpMRI Prostate Scan n=50 Participants IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions
Number of Participants With Acute Radiation Induced Genitourinary Adverse Event	4 participants	50 participants

SECONDARY outcome

Timeframe: 18 months

Biochemical (PSA) recurrence is defined according to the proposed new Radiation Therapy Oncology Group/American Society for Therapeutic Radiology and Oncology (RTOG-ASTRO) criteria also known as the RTOG Phoenix definition: an increase of the PSA level at least 2 ng/mL greater than the minimum level reached after therapy (lowest PSA+ 2 criterion). PSA failure at 1, 2, and 5 years will be estimated for each cohort by the cumulative incidence method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

The disease-free survival duration will be measured from the date of registration to the date of documentation of disease progression or until the date of death from any cause. DFS at 1, 2, and 5 years will be estimated for each c o h o r t by the Kaplan-Meier method. Also, 95% confidence intervals will be reported.

Outcome measures

Outcome data not reported

Adverse Events

Negative mpMRI Prostate Scan

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Positive mpMRI Prostate Scan

Serious events: 50 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Negative mpMRI Prostate Scan n=4 participants at risk SBRT to the whole prostate SBRT to whole prostate: Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate	Positive mpMRI Prostate Scan n=50 participants at risk IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions: Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions
Gastrointestinal disorders Other acute/late grade 1-2 GI/GU event	100.0% 4/4 • Number of events 4 • Adverse event data collected up to 54 months from registration.	96.0% 48/50 • Number of events 48 • Adverse event data collected up to 54 months from registration.
Gastrointestinal disorders grade late GU toxicity	0.00% 0/4 • Adverse event data collected up to 54 months from registration.	4.0% 2/50 • Number of events 2 • Adverse event data collected up to 54 months from registration.

Other adverse events

Adverse event data not reported

Additional Information

Dian Wang, MD

Rush University Medical Center

Phone: (708) 660-3476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place