Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Prostate Cancer Clinical Trial

Official title:

Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03284151
• Other study ID #: CYM6 Prostate CFB2
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: January 2023

Study information

• Verified date: June 2022
• Source: Centre Francois Baclesse, Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Description:

Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).

Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.

Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.

Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder neck and urethra: V35<1cc.

Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: January 2023
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Prostatic adenocarcinoma of Capra score=2 invading no more than two adjacent of the 12 prostatic zones. Lesions>3mm. Maximal urinary flow rate = 10ml/s, mean flow rate = 5ml/s, post micturation volume =80ml, IPSS score =15.

Exclusion Criteria:

• systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Cyberknife

Locations

Country	Name	City	State
Luxembourg	Centre Francois Baclesse	Esch Sur Alzette

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse, Luxembourg

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay between the initial diagnosis and date of salvage treatment	Delay between the initial diagnosis and date of salvage treatment	through study completion, up to 36 months
Secondary	PSA evaluation	PSA dosage	3, 6, 12, 18, 24, 30, 36 months
Secondary	Birads score evaluation	Multiparametric prostatic MRI	12, 24, 36 months
Secondary	Acute and late toxicity	Acute and late toxicity using the CTCAEv4	3, 6, 12, 18, 24, 30, 36 months
Secondary	IPSS evaluation	IPSS score	12, 24, 36 months
Secondary	IIEF5 evaluation	IIEF5 score	12, 24, 36 months