Phase II study of extreme hypofractionated radiotherapy for localized prostate cancer

Phase II single-centre trial of Extreme Hypofractionated RAdiotherapy for low, intermediate and high-risk localised Prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19419439

Enrollment

120

Registered

2018-07-23

Start date

2013-06-01

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Low, intermediate and highrisk prostate cancer Cancer Low, intermediate and high risk neoplasm of prostate

Interventions

Participants with low, intermediate and high risk prostate cancer received extreme hypofractionated radiotherapy using helical tomotherapy, with online guided MVCT and an endorectal balloon. This radi

for those with high-risk prostate cancer, this consisted of 2-3 years of 6 month LHRH analogue and 1 month bicalutamide. Patients will be interviewed at least 2, 6, 12, 18, 24, 30, 36, 48 and 60 mont

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. cT1-T3 N0 M0 prostate cancer 2. International Prostate Symptoms Score < 21 3. No acute urinary retention or urethral surgery in the last 6 months 4. Aged 18 years or older 5. Signed specific informant consent form

Exclusion criteria

Exclusion criteria: 1. Hip prosthesis 2. Contraindication for radical radiotherapy such as active inflamatory bowel disease, previous pelvic radiotherapy 3. Intense low urinary tract symptoms, IPSS > 20 4. Inability to understand and appreciate the nature and consequences of health decisions

Design outcomes

Primary

Measure	Time frame
The following are measured at the baseline and 2, 6, 12, 18, 24, 30, 36, 48 and 60 months after radiotherapy and every year afterwards: 1. Urinal and intestinal toxicities measured using CTCAE (Common Toxicity Criteria Adverse Effects) scale 2. Health-related quality of life measured using EPIC-26 (Expanded Prostate Cancer Index Composite short form)	—

Secondary

Measure	Time frame
1. PSA relapse free survival (nadir+2 ng/ml) is measured using total PSA levels (determined through blood test performed a few weeks before visit) measured at the baseline and 2, 6, 12, 18, 24, 30, 36, 48 and 60 months after radiotherapy and every year afterwards 2. Metastases-free survival is measured using a CT scan and bone scan, evaluated at the baseline and every 6 months only after a biochemical relapse is diagnosed (PSA > 2 ng + nadir, ASTRO definition)	—

Measure

Time frame

1. PSA relapse free survival (nadir+2 ng/ml) is measured using total PSA levels (determined through blood test performed a few weeks before visit) measured at the baseline and 2, 6, 12, 18, 24, 30, 36, 48 and 60 months after radiotherapy and every year afterwards 2. Metastases-free survival is measured using a CT scan and bone scan, evaluated at the baseline and every 6 months only after a biochemical relapse is diagnosed (PSA > 2 ng + nadir, ASTRO definition)

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026