Combined LDR Boost and HDR Whole Gland

NCT03323879 | Terminated Phase 1 DMC

• 1 other identifier: DELIGHT
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma Prostate

Keywords

brachytherapy; LDR; HDR; monotherapy; focal

Outcome Measures

Primary Outcomes (1)

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

  Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0

  At 3 months

Secondary Outcomes (3)

• Late urinary and rectal toxicity using NCI CTCAE v4.0

  3-monthly for first year, then 6-monthly until Year 5

• Health related quality of life (HRQOL) changes

  3 monthly for first year, then annually year 1-5

• Disease Free Survival

  will be reported at 5 years

Study Arms (1)

LDR/HDR

EXPERIMENTAL

MRI planned LDR boost to DIL with concurrent whole gland 19 Gy HDR. LDR dose will be sequentially escalated from 50 Gy to 80 Gy

Radiation: LDR/HDR

Interventions

LDR/HDR RADIATION

Focal LDR to dominant lesion with whole gland 19 Gy HDR

LDR/HDR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential dose escalation design

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: October 27, 2017
• Study Start: October 30, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

CA (1)