Trial Outcomes & Findings for Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (NCT NCT01578902)

NCT ID: NCT01578902

Last Updated: 2020-12-17

Results Overview

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: Acute period (up to 6 months)
• Results posted on: 2020-12-17

Participant Flow

Patients were prospectively recruited from the Odette Cancer Centre from Oct 2006 to July 2008.

Participant milestones

Measure	Hypofractionated Radiation 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. Hypofractionated radiotherapy: 35Gy/5 fractions/29 days
Overall Study STARTED	84
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Patients n=84 Participants Inclusion criteria were men over 18 years of age with histologically confirmed diagnosis of adenocarcinoma of the prostate. Only patients with clinical stage T1-T2b (TNM 2002) \[18\] Gleason Sum 66 and PSA 610 ng/ml were eligible. Neoadjuvant androgen deprivation therapy (ADT) was allowed for cytoreduction. Patients were excluded if they had prior pelvic radiation therapy, a bleeding diathesis which precluded safe gold seed insertion, the presence of hip prosthesis or pelvic girth \>40 cm. Lastly, prostate size \>90cm3 on imaging or severe lower urinary tract symptoms (IPSS \> 19)
Age, Categorical <=18 years	0 Participants n=84 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=84 Participants
Age, Categorical >=65 years	44 Participants n=84 Participants
Age, Continuous	67 years n=84 Participants
Sex: Female, Male Female	0 Participants n=84 Participants
Sex: Female, Male Male	84 Participants n=84 Participants
Region of Enrollment Canada	84 participants n=84 Participants

PRIMARY outcome

Timeframe: Acute period (up to 6 months)

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Outcome measures

Measure	Hypofractionated Radiation n=84 Participants 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Incidence of Grade 3+ Gastrointestinal Toxicity	0 participants

SECONDARY outcome

Timeframe: Acute (up to 6 months) and Late (6 months and after)

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Outcome measures

Measure	Hypofractionated Radiation n=84 Participants 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Incidence of Grade 3+ Genitourinary Toxicity	1 Participants

SECONDARY outcome

Timeframe: Late (6 months and after)

Population: low risk prostate cancer patients were treated with SABR 35Gy in 5 fractions over 29 days

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Outcome measures

Measure	Hypofractionated Radiation n=84 Participants 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Incidence of Grade 3+ Rectal and Urinary Toxicity Acute GU grade 3+ toxicity	1 participants
Incidence of Grade 3+ Rectal and Urinary Toxicity Acute GI grade 3+ toxicity	0 participants
Incidence of Grade 3+ Rectal and Urinary Toxicity Late GU grade 3+ toxicity	0 participants
Incidence of Grade 3+ Rectal and Urinary Toxicity Late GI grade 3+ toxicity	1 participants

SECONDARY outcome

Timeframe: up to 5 years

Population: Patients were low risk prostate cancer patients treated with SABR 35Gy in 5 fractions over 29 days.

Expanded Prostate Cancer Index Composite (EPIC)

Outcome measures

Measure	Hypofractionated Radiation n=84 Participants 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Patient Reported Quality of Life Bowel quality of life change	22 percentage with change in QOL
Patient Reported Quality of Life Bladder quality of life change	16 percentage with change in QOL
Patient Reported Quality of Life Sexual quality of life change	33 percentage with change in QOL

SECONDARY outcome

Timeframe: 5 year

Population: low risk prostate cancer patients treated with SABR 35 Gy in 5 fractions over 29 days

Failure = Follow-up PSA greater than nadir PSA + 2 ng/ml

Outcome measures

Measure	Hypofractionated Radiation n=84 Participants 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Biochemical (ie. Prostate Specific Antigen) Disease Free Survival	96 percent Interval 91.5 to 100.0

SECONDARY outcome

Timeframe: 3 year

Population: low risk prostate cancer patients treated with SABR 35 Gy in 5 fractions over 29 days

Patients were biopsied at 3 years post treatment

Outcome measures

Measure	Hypofractionated Radiation n=84 Participants 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Biopsy Positive Rate	3 Participants

Adverse Events

Hypofractionated Radiation

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hypofractionated Radiation n=84 participants at risk 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Renal and urinary disorders acute urinary retention	1.2% 1/84 • Number of events 1
Gastrointestinal disorders rectalcutaneous fistula	1.2% 1/84 • Number of events 1

Other adverse events

Measure	Hypofractionated Radiation n=84 participants at risk 35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days. The co-primary outcome variable (Grade 3+ acute gastrointestinal toxicity) was observed in 0% of patients.
Renal and urinary disorders acute grade 2 genitourinary	19.0% 16/84 • Number of events 16
Gastrointestinal disorders acute grade 2 gastrointestinal toxicity	9.5% 8/84 • Number of events 8
Gastrointestinal disorders late grade 2 gastrointestinal toxicity	7.1% 6/84 • Number of events 6
Renal and urinary disorders late grade 2 genitourinary toxicity	6.0% 5/84 • Number of events 5
Gastrointestinal disorders late grade 3+ GI toxicity	1.2% 1/84 • Number of events 1
Renal and urinary disorders late grade 3+ GU toxicity	0.00% 0/84
Renal and urinary disorders acute grade 3+ GU toxicity	1.2% 1/84 • Number of events 1

Additional Information

Dr Andrew Loblaw, Director GU Radiation Trials

Sunnybrook Research Institute

Phone: 4164804806

Email: andrew.loblaw@sunnybrook.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place