Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer (pHART8)
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ClinicalTrials.gov Identifier: NCT01505075 |
Recruitment Status :
Active, not recruiting
First Posted : January 6, 2012
Last Update Posted : May 31, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Radiation: Hypofractionated radiation | Phase 1 Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer |
Actual Study Start Date : | September 2011 |
Actual Primary Completion Date : | January 2013 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Hypofractionated radiation
40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
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Radiation: Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Other Name: RapidArc |
- Incidence of grade 3+ rectal toxicity [ Time Frame: Acute period (up to 3 months) ]Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- Incidence of grade 3+ urinary toxicity [ Time Frame: 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 [ Time Frame: 5 years ]Expanded Prostate Cancer Index Composite (EPIC)
- Biochemical (ie.prostate specific antigen) disease free survival [ Time Frame: 5 years ]
- Incidence of grade 3+ rectal toxicity [ Time Frame: Late (after 6 months of follow-up) ]Common Terminology Criteria for Adverse Events (CTCAE) v3.0

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505075
Canada, Ontario | |
Odette Cancer Centre, Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 |
Principal Investigator: | Andrew Loblaw, MD, FRCPC | Sunnybrook Health Sciences Centre | |
Principal Investigator: | Suneil Jain, MD | suneil.jain@sunnybrook.ca |
Responsible Party: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT01505075 History of Changes |
Other Study ID Numbers: |
043-2011 |
First Posted: | January 6, 2012 Key Record Dates |
Last Update Posted: | May 31, 2019 |
Last Verified: | May 2019 |
prostatic neoplasms radiotherapy hypofractionated high risk prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |