Prospective Outcomes-analysis for localised Prostate Adenocarcinoma after Radiotherapy Treatment

Phase 4

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12606000157572
• Lead Sponsor: Department of radiation oncology, St George Hospital, Kogarah 2217

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 78

Inclusion Criteria

All Study groups:· Histologically confirmed adenocarcinoma of the prostate eligible for curative treatment · N0M0 i.e. cancer confined to the prostate only with no lymph nodes or other organ involvement· Good performance status (ECOG 0-1)· Patient is mentally, physically and geographically capable of undergoing treatment and follow-up. No significant co-morbidity limiting life expectancy to < 5 years· No diabetes mellitus or other significant neurological disorders that may affect pelvic nerve function· No other malignancy diagnosed within the last 5 years, except non-melanotic skin cancers· Informed consent signed.Brachytherapy groups:Specific Inclusion criteria· No previous TURP (surgical urethral scraping)· Prostate volume < 50cc for LDR and < 75cc prior to hormonal therapy for HDR· Stage T1c to T2a for LDR (i.e. prostate cancer confined to 1 lobe of prostate) and stage T1c-T4 for HDR provided the tumour volumes are encompassable within a radiation portal.· Able to undergo general anaesthetics and obtain dorso-lithortomy position· PSA <10ng/ ml for LDR· No bilateral total hip replacement as this interferes with obtaining CT images for radiotherapy planning (unless pre-procedure CT performed demonstrates adequate visualisation of the prostate target volume)· Ability to assume dorso-lithotomy position· No bleeding disorders or on anti-coagulations that increases patients’ risk of intra-operative bleeding.

Exclusion Criteria

Prior radiation therapy to the pelvis. Poor performance status (ECOG 2 or above).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anorectal Function following curative radiotherapy[Measured at baseline, then 6 weeks and 12 months after radiotherapy.];Lower urinary tract function following curative radiotherapy[Measured at baseline, then 6 weeks and 12 months after radiotherapy.];Quality of life following curative radiotherapy[Measured at baseline, then 6 weeks and 12 months after radiotherapy.]

Secondary Outcome Measures

Name	Time	Method
Sexual function[At baseline, 6 weeks and 12 months after treatment of radiotherapy.];Relapse-free survival[At 2 years after treatment.]