Prospective multi-centre study of low-dose Iodine125 (I-125) prostate brachytherapy performed after transurethral resection. PROBATE study

Prospective multi-centre study of low-dose Iodine125 (I-125) prostate brachytherapy performed after transurethral resection. PROBATE study - I125 postTURP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37110

Enrollment

Registered

2012-11-12

Start date

2013-08-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer prostate malignancy

Interventions

Brachytherapy with I-125 sources

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D*Amico classification. -Prostate volume

Exclusion criteria

Exclusion criteria: -Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer -High grade tumours defined by Gleason score 8 or above -Co-morbidity which would exclude the patient from a transperineal implant procedure.

Design outcomes

Primary

Measure	Time frame
Acute and late urinary toxicity defined by IPSS and CTCAEv4	—

Secondary

Measure	Time frame
- Gastro-intestinal and sexual function - Biochemical disease free survival (Phoenix-definition). - Incidence of seed loss at 1month and 6 months after implant	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)