A prospective trial investigating the safety and efficacy of dose-escalated radiotherapy for men with prostate cancer following insertion of a gel spacer between the prostate and rectum

Not Applicable

Completed

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12621000056897
• Lead Sponsor: Epworth HealthCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-18
• Study Start: 2021-01-22
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

1. Pathologically confirmed clinical stage T1 or T2 or T3 invasive adenocarcinoma of the prostate (any PSA, any Gleason score).
2. Males greater than 18 years old
3. Candidate for radical Intensity Modulated Radiotherapy.
4. ECOG performance status of 0 or 1.
5. Able to provide written informed consent, or consent can be provided by
authorized representative and approved by the appropriate Institutional
Review Board (IRB) of the respective clinical site.
6. Neo-adjuvant or adjuvant hormone therapy allowed

Exclusion Criteria

1. Evidence of metastatic disease to the lymph nodes, bone or lung
2. Planned or previous pelvic or lymph node radiotherapy
3. Any other active malignancy (untreated, progressive or recurrent), except for
non-melanoma skin cancer.
4. Any inactive malignancy diagnosed within 5 years of entry, except for non- melanoma skin cancer.
5. Inflammatory bowel disease (active) such as Crohn’s disease and ulcerative colitis.
6. Active bleeding disorder.
7. Inflammatory bowel disease, chronic prostatitis or any urogenital anatomic
abnormality that would interfere with the ability to access the SpaceOAR® hydrogel injection site

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of clinically notifiable Gastrointestinal (GI) and Genitourinary (GU) toxicity and adverse events (CTCAE V4.0 Grade III or higher)[6 weeks following completion of radiotherapy, then 3 monthly up until 18 months, then 6 monthly up until 36 months post radiotherapy];Patient determined quality of life using EORTC QLQ-C30 (version 3)[6 weeks following completion of radiotherapy, then 3 monthly up until 18 months, then 6 monthly up until 36 months post radiotherapy];Patient determined quality of life using QLQ-PR25 assessment[6 weeks following completion of radiotherapy, then 3 monthly up until 18 months, then 6 monthly up until 36 months post radiotherapy]