SBRT in 4 Fractions for Prostate Cancer

Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03873090

Enrollment

Registered

2019-03-13

Start date

2013-06-12

Completion date

2018-05-23

Last updated

2019-03-13

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

Conditions

Prostate Cancer

Brief summary

This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days.

Interventions

OTHERSBRT

hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Age ≤ 85years. * WHO performance status ≤ 2. * PSA\>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c. * Histologically proven prostate adenocarcinoma * No pathologic lymph nodes on CT/ MRI scan. * No distant metastases. * No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT). * No malignant tumours in the previous 5 years. * IPSS 0-7. * Combined HT according to risk factors. * Informed consent.

Exclusion criteria

* Prostate size greater than 60cc. * Previous TURP less than 6 weeks before radiotherapy. * Previous prostate surgery other than TURP. * Diabetes \*. * Use of anticoagulants drugs \*. * Chronic inflammatory bowel disease \*. * Previous pelvic irradiation. * Inability to obtain written informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.	up to 5 years	Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
Tumour response to local radiation therapy by assessing freedom from biochemical failure.	up to 5 years	Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026