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Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00126165
Enrollment
72
Registered
2005-08-03
Start date
2004-09-30
Completion date
2011-08-31
Last updated
2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, radiotherapy, hypofraction, radiosensitivity, image-guidance

Brief summary

This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Detailed description

This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Interventions

PROCEDUREradiotherapy

Sponsors

Calgary Health Region
CollaboratorOTHER
Alberta Health services
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Stage T1 and T2 prostate cancer * Prostate specific antigen (PSA)\>=20 and Gleason score\<=6 * PSA\<=15 and Gleason score 7 * Signed informed consent

Exclusion criteria

* No hip prosthesis, pins or screws * No previous pelvic radiotherapy * No inflammatory bowel disease

Design outcomes

Primary

MeasureTime frame
rectal morbidity

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026