TerminatedPhase 1/2

Combined LDR Boost and HDR Whole Gland

Stopped: Slow accrual

Canada7 participantsStarted 2017-10-30

Plain-language summary

This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early toxicity.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed Adenocarcinoma of the prostate * Single PIRADS 4 or 5 lesion on multiparametric MRI * T1c-T2b on rectal exam * Gleason 3+3 and PSA \< 20ng/mL * Gleason 3+4 and PSA \<10ng/mL * Less than 50% of the cores positive in an untargeted prostate biopsy. * Prostate volume \< 60 cc Exclusion Criteria: * Incapable or ineligible for MRI imaging * Previous trans-urethral resection of prostate (TURP) * Previous or current use of androgen deprivation * Baseline International Prostate Symptom Score (IPSS) \> 15 * Evidence of distant or nodal metastasis * Disease that contraindicates treatment with radiation (e.g connective tissue disease) * Unsuitable for anesthesia due to comorbidity

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0

Timeframe: At 3 months

Trial details

NCT IDNCT03323879

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Carcinoma Prostate trials