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RE-irradiation for Isolated FOCal Recurrence of Prostate Cancer With Ultrahypofracted SBRT

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorEuropean Institute of Oncology

About this trial

Prostate cancer (PCa) is one of the most frequently diagnosed malignancies in men worldwide, with the highest prevalence observed in developed countries. Patients affected by localized disease can be treated with several local modalities, including radical prostatectomy (RP), external beam radiotherapy (EBRT) and brachytherapy (BT). Although the advances in treatment strategies, after primary treatment 5 to 60% of men experience biochemical recurrence (BCR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 and < 80 years

Histologically confirmed adenocarcinoma of the prostate initial diagnosis

History of a previous adjuvant/salvage RT following prostatectomy or curative RT

Diagnosis of local recurrence at the restaging imaging in hormone sensitive patients (maximum 1 prostate bed recurrence and 3 intraprostatic recurrences)

Disqualifiers

Evidence of distant metastasis at the restaging imaging

Patients with current concomitant anticoagulant therapy (antiplatelet therapy is allowed even if it will be temporary suspended before fiducials implant)

Platelets count < 75'000/uL

Urethral stricture

Trial population

All enrolled patients will receive standard-of-care CyberKnife-based SBRT to the pelvic target. Androgen deprivation therapy (ADT), including its indication, timing, and duration, will be prescribed at the discretion of the treating radiation oncologist based on clinical judgment and individual patient characteristics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Acute GU adverse events

Acute GU adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)

Time frame
at the end of treatment and 3 months after the end of treatment
2

Acute GI adverse events

Acute GI adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)

Time frame
at the end of treatment and 3 months after the end of treatment
3

questionnaire IIEF-5

The patient fills out the questionnaire IIEF-5

Time frame
At the baseline and from the end of radiotherapy through study completion, every three months.
4

questionnaire IPSS

The patient fills out the questionnaire IPSS

Time frame
At the baseline and from the end of radiotherapy through study completion, every three months.

Secondary outcomes

1

Biochemical progression-free survival (bPFS)

Defined as the time from the end of re-RT to either biochemical recurrence (BCR) or last follow-up. bPFS will be assessed through trimestral PSA evaluation from the end of treatment.

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: