Trial Outcomes & Findings for Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy (NCT NCT00450411)

NCT ID: NCT00450411

Last Updated: 2022-06-21

Results Overview

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: Between 271 days and 730 days from date of implantation
• Results posted on: 2022-06-21

Participant Flow

Participant milestones

Measure	Brachytherapy Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Overall Study STARTED	100
Overall Study Eligible and Started Protocol Treatment	92
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Brachytherapy Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Overall Study Protocol Violation	6
Overall Study No protocol treatment	2

Baseline Characteristics

Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

Baseline characteristics by cohort

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants

PRIMARY outcome

Timeframe: Between 271 days and 730 days from date of implantation

Population: Eligible patients who received protocol treatment with at least 23 months follow-up from the date of implantation

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.

Outcome measures

Measure	Brachytherapy n=87 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)	12 Participants

SECONDARY outcome

Timeframe: From date of implantation to 270 days

Population: Eligible patients who received protocol treatment with at least 270 days of follow-up from the date of implantation

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, acute treatment-related adverse events will be evaluated within 270 days from the implant.

Outcome measures

Measure	Brachytherapy n=88 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Number of Patients With Acute Treatment-related GI and GU Adverse Events	12 Participants

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible and started protocol treatment

Survival time is defined as time from registration to date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all patients were potentially observed for at least 5 years from registration.

Outcome measures

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Percentage of Participants Alive at 5 Years (Overall Survival)	92.2 percentage of participants Interval 86.7 to 97.8

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible and started protocol treatment

An event for disease-free survival is defined as local progression, distant progression, biochemical failure, initiation of salvage hormone therapy, or death due to any cause.Biochemical failure is defined as a rise in prostate-specific antigen (PSA) by at least 2 ng/mL over the current nadir. Local progression is defined as documented progressive disease on digital rectal examination or a post-implant prostate biopsy showing carcinoma. Distant progression is defined as documented lymphatic or hematogenous metastatic disease. Disease-free survival time is defined as time from registration to the date of first event or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.

Outcome measures

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Percentage of Participants Alive Without Disease (Disease-free Survival)	61.2 percentage of participants Interval 51.1 to 71.3

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible and started protocol treatment

An event for prostate cancer death is defined as any of the following: primary cause of death certified as due to prostate cancer, death associated with tumor progression occurring after initiation of salvage anti-tumor therapy, death associated with a rise in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy, death associated with disease progression in the absence of any anti-tumor therapy, or death from a complication of protocol therapy irrespective of disease status. Time to prostate cancer death is defined as time from registration to date of first event, last known follow-up (censored), or death unrelated to prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.

Outcome measures

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)	92.2 percentage of participants Interval 86.7 to 97.8

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible and started protocol treatment

Local progression is defined as documented progressive disease on digital rectal examination or a post-implant prostate biopsy showing carcinoma. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Analysis occurred after all patients were potentially observed for at least 5 years from registration.

Outcome measures

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Percentage of Participants With Local Failure at 5 Years	3.3 percentage of participants Interval 0.9 to 8.6

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible and started protocol treatment

Distant failure is defined as documented lymphatic or hematogenous metastatic disease. Time to distant failure is defined as time from registration to the date of first distant failure, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.

Outcome measures

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Percentage of Participants With Distant Failure at 5 Years	10.0 percentage of participants Interval 4.9 to 17.2

SECONDARY outcome

Timeframe: From registration to 5 years

Population: Eligible and started protocol treatment

Biochemical failure is defined as PSA 2 ng/ml or more higher than the nadir PSA value, or initiation of hormone therapy at any time after brachytherapy. (If the PSA rise is within 36 months following brachytherapy and is followed by a subsequent non-hormonal induced PSA decrease, the patient will not be considered as a failure.) Time to biochemical failure is defined as time from registration to the date of first biochemical failure, last known follow-up (censored), or death without local recurrence (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.

Outcome measures

Measure	Brachytherapy n=92 Participants Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Percentage of Participants With Biochemical Failure at 4 Years	32.2 percentage of participants Interval 22.8 to 42.0

Adverse Events

Brachytherapy

Serious events: 8 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Measure	Brachytherapy n=92 participants at risk Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Gastrointestinal disorders Diarrhea	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
General disorders Edema limbs	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Infections and infestations Prostate infection [with unknown ANC]	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Cystitis	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Hemorrhage urinary tract	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urethral obstruction	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urethral stricture	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urinary frequency	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urinary retention	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urogenital disorder	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.1% 1/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.

Other adverse events

Measure	Brachytherapy n=92 participants at risk Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Gastrointestinal disorders Constipation	12.0% 11/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Gastrointestinal disorders Diarrhea	16.3% 15/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Gastrointestinal disorders Fecal incontinence	10.9% 10/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Gastrointestinal disorders Proctitis	16.3% 15/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Gastrointestinal disorders Rectal hemorrhage	25.0% 23/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Gastrointestinal disorders Rectal pain	6.5% 6/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
General disorders Fatigue	31.5% 29/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Infections and infestations Urinary tract infection [with unknown ANC]	7.6% 7/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Psychiatric disorders Libido decreased	25.0% 23/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Bladder hemorrhage	8.7% 8/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Bladder pain	22.8% 21/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Bladder spasm	9.8% 9/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Cystitis	35.9% 33/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Hemorrhage urinary tract	25.0% 23/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urethral hemorrhage	7.6% 7/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urethral obstruction	9.8% 9/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urethral pain	16.3% 15/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urethral stricture	7.6% 7/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urinary frequency	90.2% 83/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urinary incontinence	63.0% 58/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urinary retention	59.8% 55/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Renal and urinary disorders Urogenital disorder	18.5% 17/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Reproductive system and breast disorders Ejaculation disorder	16.3% 15/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Reproductive system and breast disorders Erectile dysfunction	58.7% 54/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Reproductive system and breast disorders Prostatic pain	6.5% 6/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.
Vascular disorders Hot flashes	14.1% 13/92 • 1, 3, 6, 9, and 12 months following implant, then every 6 months for years 2-5, then annually. Maximum follow-up at time of analysis was 11.2 years.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: seiferheldw@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER