Trial Outcomes & Findings for Hypofractionated SBRT For Prostate Cancer (NCT NCT00977860)

Results Overview

Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

163 participants

Primary outcome timeframe

Up to 90 days

Results posted on

2024-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	SBRT Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Overall Study STARTED	163
Overall Study COMPLETED	163
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypofractionated SBRT For Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT n=163 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Age, Continuous	67.80 years STANDARD_DEVIATION 6.929 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	162 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	148 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 days

Population: Patients that received SBRT therapy.

Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	SBRT n=2 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Rate of Acute Grade 3 or Higher GI and GU Toxicities	2 Participants

PRIMARY outcome

Timeframe: After 90 days post-treatment, up to 5 years per patient

Population: All enrolled patients that received SBRT therapy.

Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	SBRT n=163 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Rate of Late Grade 3 or Higher GI and GU Toxicities	0 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: All enrolled patients that received SBRT therapy with PSA assessment.

Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA \> 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.

Outcome measures

Outcome measures
Measure	SBRT n=163 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Biochemical Disease-Free Survival Rate (bDFS)	7 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Data were not collected.

Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Data were not collected.

Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 5 years

Population: All patients that received SBRT therapy.

Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.

Outcome measures

Outcome measures
Measure	SBRT n=163 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
5-year Overall Survival (OS)	93.87 percentage of participants

SECONDARY outcome

Timeframe: Prior to start of therapy

Population: Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.

The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.

Outcome measures

Outcome measures
Measure	SBRT n=36 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Quality of Life (QoL) - FACT-G - Prior to Therapy EWB	19.58 score on a scale Standard Deviation 4.449
Quality of Life (QoL) - FACT-G - Prior to Therapy FWB	23.44 score on a scale Standard Deviation 5.417
Quality of Life (QoL) - FACT-G - Prior to Therapy FACTG	92.78983 score on a scale Standard Deviation 12.323307
Quality of Life (QoL) - FACT-G - Prior to Therapy PWB	26.06019 score on a scale Standard Deviation 2.716213
Quality of Life (QoL) - FACT-G - Prior to Therapy SWB	23.70186 score on a scale Standard Deviation 3.641432

SECONDARY outcome

Timeframe: At 24 months (post-start of therapy)

Population: Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.

The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.

Outcome measures

Outcome measures
Measure	SBRT n=21 Participants Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Quality of Life (QoL) - FACT-G - At 24 Months SWB	21.95238 score on a scale Standard Deviation 6.645819
Quality of Life (QoL) - FACT-G - At 24 Months PWB	26.10 score on a scale Standard Deviation 2.791
Quality of Life (QoL) - FACT-G - At 24 Months EWB	21.25 score on a scale Standard Deviation 3.370
Quality of Life (QoL) - FACT-G - At 24 Months FWB	22.85 score on a scale Standard Deviation 5.824
Quality of Life (QoL) - FACT-G - At 24 Months FACTG	93.15000 score on a scale Standard Deviation 14.605211

Adverse Events

SBRT

Serious events: 2 serious events

Other events: 9 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	SBRT n=163 participants at risk Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Renal and urinary disorders Incontinence	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders Nocturia	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders Hematuria	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders Urinary frequncy	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders Dysuria	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.

Other adverse events

Other adverse events
Measure	SBRT n=163 participants at risk Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Gastrointestinal disorders Diarrhea	3.1% 5/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders Urinary frequency/urgency	4.9% 8/163 • Adverse event data were collected for a period of up to 5 years.
General disorders Fatigue (asthenia, lethargy, malaise)	1.2% 2/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders Other	1.8% 3/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders nocturia	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Renal and urinary disorders weak stream	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Investigations hypercholesteremia	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Skin and subcutaneous tissue disorders Burning - tip of penis	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.
Psychiatric disorders anxiety	0.61% 1/163 • Adverse event data were collected for a period of up to 5 years.

Additional Information

Barbara M Stadterman, MPH, MCCR

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place