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Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy

NCT02976402 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-23

No results posted yet for this study

Summary

The present phase I trial evaluates the feasibility of a postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely.

Eligible patients for this study are those with:

* Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
* Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement
* Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of \> 0.1 - ≤ 2.0 ng/mL)
* Life expectancy: 10 years
* ECOG performance status of 0 -1
* No distant metastases, based on the following workup within 60 days prior to registration
* Magnetic resonance imaging (MRI) of the pelvis
* PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence
* Patients can be on androgen deprivation therapy
* Ability to understand and willingness to sign a study-specific informed consent prior to study.

Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.

Conditions

  • Prostate Cancer Adenocarcinoma
  • Adjuvant Radiotherapy
  • Salvage Radiotherapy
  • SBRT
  • IGRT
  • Urethral Sparing

Interventions

RADIATION

SBRT

Postoperative RT consisting in: * 31 Gy in 5 sessions each of 6.2 Gy (adjuvant intent) delivered in one week * 32.5 Gy in 5 sessions each of 6.5 Gy (salvage intent) delivered in one week

Sponsors & Collaborators

  • Fundacao Champalimaud

    lead OTHER

Principal Investigators

  • Carlo Greco, M.D. · Champalimaud Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02976402 on ClinicalTrials.gov