NCT00977860

Hypofractionated SBRT For Prostate Cancer

Completed NA Results posted Last updated 2 May 2024

What this trial tests

NA trial testing Stereotactic Body Radiation Therapy in Prostate Cancer in 163 participants. Completed in 8 July 2022.

Timeline

7 October 2010

Primary endpoint
8 July 2022

8 July 2022

Quick facts

Lead sponsor	Adam Olson
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	163
Start date	7 October 2010
Primary completion	8 July 2022
Estimated completion	8 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Stereotactic Body Radiation Therapy — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Adam Olson — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Acute Grade 3 or Higher GI and GU Toxicities Primary · Up to 90 days

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.

Group	Value	95% CI
SBRT	2

Rate of Late Grade 3 or Higher GI and GU Toxicities Primary · After 90 days post-treatment, up to 5 years per patient

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.

Group	Value	95% CI
SBRT	0

Biochemical Disease-Free Survival Rate (bDFS) Primary · Up to 5 years

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.

Group	Value	95% CI
SBRT	7

5-year Overall Survival (OS) Secondary · At 5 years

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

Group	Value	95% CI
SBRT	93.87

Quality of Life (QoL) - FACT-G - Prior to Therapy Secondary · Prior to start of 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 muc

PWB

Group	Value	95% CI
SBRT	26.06019	± 2.716213

SWB

Group	Value	95% CI
SBRT	23.70186	± 3.641432

EWB

Group	Value	95% CI
SBRT	19.58	± 4.449

FWB

Group	Value	95% CI
SBRT	23.44	± 5.417

FACTG

Group	Value	95% CI
SBRT	92.78983	± 12.323307

Quality of Life (QoL) - FACT-G - At 24 Months Secondary · At 24 months (post-start of 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 muc

PWB

Group	Value	95% CI
SBRT	26.10	± 2.791

SWB

Group	Value	95% CI
SBRT	21.95238	± 6.645819

EWB

Group	Value	95% CI
SBRT	21.25	± 3.370

FWB

Group	Value	95% CI
SBRT	22.85	± 5.824

FACTG

Group	Value	95% CI
SBRT	93.15000	± 14.605211

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for a period of up to 5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SBRT

Serious: 2/163 (1%)

Deaths: 15/163

Serious adverse events (5 terms)

Reaction	System	SBRT
Incontinence	Renal and urinary disorders	—
Nocturia	Renal and urinary disorders	—
Hematuria	Renal and urinary disorders	—
Urinary frequncy	Renal and urinary disorders	—
Dysuria	Renal and urinary disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	SBRT
Urinary frequency/urgency	Renal and urinary disorders	—
Diarrhea	Gastrointestinal disorders	—
Other	Renal and urinary disorders	—
Fatigue (asthenia, lethargy, malaise)	General disorders	—
nocturia	Renal and urinary disorders	—
weak stream	Renal and urinary disorders	—
hypercholesteremia	Investigations	—
Burning - tip of penis	Skin and subcutaneous tissue disorders	—
anxiety	Psychiatric disorders	—

Most-reported serious reactions: Incontinence, Nocturia, Hematuria, Urinary frequncy, Dysuria.

Data from ClinicalTrials.gov NCT00977860 adverse events section.

Sponsor's own description

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.