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Clinical Trials/NCT02313298
NCT02313298
Unknown
Phase 2

A Phase II Trial of Prostate Stereotactic Radiotherapy

National Cancer Centre, Singapore1 site in 1 country80 target enrollmentJune 2013
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ConditionsProstate Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
National Cancer Centre, Singapore
Enrollment
80
Locations
1
Primary Endpoint
The rate of late severe GI and GU toxicities
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.

Detailed Description

This is a single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) with the aid of volumetric image guidance to ensure accuracy. Toxicity will be measured at preset intervals, as will HRQOL parameters using the Expanded Prostate Index Composite (EPIC) questionaire which focuses on bowel, urinary, sexual and hormonal symptoms.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
National Cancer Centre, Singapore
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • •History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
  • •Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-7
  • •Clinical stage T1-2b (DRE) (AJCC 7th edition) within 90 days of registration
  • •PSA \< 20 ng/mL within 60 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy. (Every effort should be made to obtain all serum PSA values obtained in the 1 year prior to treatment to allow for calculation of PSA kinetics.)
  • •Not more than one intermediate risk factor (T2b/GS7/PSA 10-20)
  • •Zubrod Performance Status 0-1 within 60 days prior to registration
  • •Patient must be able to provide study-specific informed consent prior to study entry.
  • •Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Exclusion Criteria

  • •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
  • •T-stage ≥ T2c on staging MRI
  • •Evidence of distant metastases
  • •Regional lymph node involvement
  • •Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
  • •Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • •Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy)
  • •Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.
  • •Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.
  • •Previous or concurrent cytotoxic chemotherapy for prostate cancer

Outcomes

Primary Outcomes

The rate of late severe GI and GU toxicities

Time Frame: 2 years

Secondary Outcomes

  • Freedom from biochemical recurrence (FFBR)(1, 2 and 5 years)
  • The rate of late severe GI and GU toxicities(1 and 5 years)
  • The rate of acute severe GI and GU toxicities(1, 2 and 5 years)
  • Disease-specific survival(1, 2 and 5 years)
  • PSA failure-free survival(1, 2 and 5 years)
  • Time to distant and/or regional failure(1, 2 and 5 years)
  • Disease-free survival (DFS)(1, 2 and 5 years)
  • Time to local progression(1, 2 and 5 years)
  • The change in quality of life outcomes from baseline(1, 2 and 5 years)
  • Overall survival (OS)(1, 2 and 5 years)

Study Sites (1)

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