Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer

Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505075

Acronym

pHART8

Enrollment

Registered

2012-01-06

Start date

2011-09-30

Completion date

2021-09-30

Last updated

2020-11-24

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

Conditions

Prostate Cancer

Keywords

prostatic neoplasms, radiotherapy, hypofractionated, high risk prostate cancer

Brief summary

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).

Detailed description

Primary Endpoints: * Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities Secondary Endpoints: * Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities * Biochemical disease-free survival * Biopsy positive rate at 3 years * Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire * Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity

Interventions

RADIATIONHypofractionated radiation

40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* informed consent obtained * men \> 18 years * histologically confirmed prostate adenocarcinoma (centrally reviewed) * high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA \> 20ng/mL

Exclusion criteria

* prior pelvic radiotherapy * anticoagulation medication (if unsafe to discontinue for gold seed insertion) * diagnosis of bleeding diathesis * pelvic girth \> 40cm (to ensure visibility of gold seeds on electronic portal imaging) * large prostate (\> 90cm3) on imaging * severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \> 3) * No evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression

Design outcomes

Primary

Measure	Time frame	Description
Incidence of grade 3+ rectal toxicity	Acute period (up to 3 months)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Secondary

Measure	Time frame	Description
Incidence of grade 3+ urinary toxicity	Acute (up to 3 months) and Late (after 6 months of follow-up)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Quality of Life	5 years	Expanded Prostate Cancer Index Composite (EPIC)
Biochemical (ie.prostate specific antigen) disease free survival	5 years	—
Incidence of grade 3+ rectal toxicity	Late (after 6 months of follow-up)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026