Trial Outcomes & Findings for Observation or Radical Treatment in Patients With Prostate Cancer (NCT NCT00499174)

NCT ID: NCT00499174

Last Updated: 2023-08-23

Results Overview

Time from the date of randomization to the date of death due to prostate cancer.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: 5 years 6 months
• Results posted on: 2023-08-23

Participant Flow

Participant milestones

Measure	Active Surveillance Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression	Radical Intervention Radical prostatectomy or radiotherapy based on patient and physician preference conventional surgery: Radical prostatectomy brachytherapy: high dose rate temporary seed implant; permanent seed implant. external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy. Biopsies: Periodic repeat biopsies
Overall Study STARTED	78	102
Overall Study COMPLETED	0	93
Overall Study NOT COMPLETED	78	9

Reasons for withdrawal

Measure	Active Surveillance Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression	Radical Intervention Radical prostatectomy or radiotherapy based on patient and physician preference conventional surgery: Radical prostatectomy brachytherapy: high dose rate temporary seed implant; permanent seed implant. external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy. Biopsies: Periodic repeat biopsies
Overall Study Physician Decision	78	9

Baseline Characteristics

Observation or Radical Treatment in Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Active Surveillance n=78 Participants Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression	Radical Intervention n=102 Participants Radical prostatectomy or radiotherapy based on patient and physician preference conventional surgery: Radical prostatectomy brachytherapy: high dose rate temporary seed implant; permanent seed implant. external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy. Biopsies: Periodic repeat biopsies	Total n=180 Participants Total of all reporting groups
Age, Customized age group : 40-49	0 years n=5 Participants	2 years n=7 Participants	2 years n=5 Participants
Age, Customized age group : 50-59	9 years n=5 Participants	22 years n=7 Participants	31 years n=5 Participants
Age, Customized age group : 60-69	48 years n=5 Participants	56 years n=7 Participants	104 years n=5 Participants
Age, Customized age group : >= 70	21 years n=5 Participants	20 years n=7 Participants	41 years n=5 Participants
Age, Customized age group : Missing	0 years n=5 Participants	1 years n=7 Participants	1 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	102 Participants n=7 Participants	180 Participants n=5 Participants
Disease Stage* T1B	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Disease Stage* T1C	64 participants n=5 Participants	79 participants n=7 Participants	143 participants n=5 Participants
Disease Stage* T2A	12 participants n=5 Participants	20 participants n=7 Participants	32 participants n=5 Participants
Disease Stage* T2B	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
ECOG Performance Status* 0	73 participants n=5 Participants	98 participants n=7 Participants	171 participants n=5 Participants
ECOG Performance Status* 1	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
PSA value < 5. ug/L	43 participants n=5 Participants	55 participants n=7 Participants	98 participants n=5 Participants
PSA value >= 5. ug/L	35 participants n=5 Participants	47 participants n=7 Participants	82 participants n=5 Participants
Gleason Score (Combined)* 6	78 Participants n=5 Participants	102 Participants n=7 Participants	180 Participants n=5 Participants
Gleason Score (Combined)* Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years 6 months

Population: Due to difficulty in accruing patients to the trial, the trial was closed early, there is no patient died of prostate cancer. Thus, no analysis was done.

Time from the date of randomization to the date of death due to prostate cancer.

Outcome measures

Measure	Radical Intervention n=78 Participants Radical prostatectomy or radiotherapy based on patient and physician preference conventional surgery: Radical prostatectomy brachytherapy: high dose rate temporary seed implant; permanent seed implant. external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy. Biopsies: Periodic repeat biopsies	Active Surveillance n=102 Participants Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
Disease-specific Survival	NA years There is no patient died of prostate cancer reported in the trial, so none of the reported value is available.	NA years There is no patient died of prostate cancer reported in the trial, so none of the reported value is available.

SECONDARY outcome

Timeframe: 5 years 6 months

Population: Due to lower patients accrual rate, the trial was closed early with only 3 events reported in the trial, Thus.no formal analysis had been done.

Time from randomization to the date of death due to any causes.

Outcome measures

Measure	Radical Intervention n=78 Participants Radical prostatectomy or radiotherapy based on patient and physician preference conventional surgery: Radical prostatectomy brachytherapy: high dose rate temporary seed implant; permanent seed implant. external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy. Biopsies: Periodic repeat biopsies	Active Surveillance n=102 Participants Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression
Overall Survival	NA years There is no patient died of prostate cancer reported in the trial, so none of the reported value is available.	NA years There is no patient died of prostate cancer reported in the trial, so none of the reported value is available.

Adverse Events

Active Surveillance

Serious events: 0 serious events

Other events: 57 other events

Deaths: 1 deaths

Radical Intervention

Serious events: 0 serious events

Other events: 65 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Surveillance n=78 participants at risk Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression	Radical Intervention n=99 participants at risk Radical prostatectomy or radiotherapy based on patient and physician preference conventional surgery: Radical prostatectomy brachytherapy: high dose rate temporary seed implant; permanent seed implant. external beam radiation therapy: 3D conformal radiation therapy; intensity modulated radiation therapy. Biopsies: Periodic repeat biopsies
General disorders Fatigue	19.2% 15/78 • Number of events 15 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0	7.1% 7/99 • Number of events 7 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0
General disorders Pain Testicle	1.3% 1/78 • Number of events 1 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0	9.1% 9/99 • Number of events 9 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0
Renal and urinary disorders Incontinence, urinary	3.8% 3/78 • Number of events 3 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0	11.1% 11/99 • Number of events 11 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0
Renal and urinary disorders Urinary frequency	43.6% 34/78 • Number of events 34 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0	29.3% 29/99 • Number of events 29 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0
Renal and urinary disorders Urinary retention	15.4% 12/78 • Number of events 12 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0	12.1% 12/99 • Number of events 12 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0
Reproductive system and breast disorders Ejaculatory dysfunction	47.4% 37/78 • Number of events 37 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0	41.4% 41/99 • Number of events 41 • q 3 months for 2 years then every 6 months for 5 years and 6 months. Adverse events graded according to CTCAE V4.0

Additional Information

Keyue Ding, Biostatistician

Canadian Cancer Trials Group

Phone: 613-533-6430

Email: kding@ctg.queensu.ca

Results disclosure agreements

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