PSMA-PET guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer

Phase 3

Recruiting

Conditions: Prostate cancer
10038597

Registration Number: NL-OMON52569

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 538

Inclusion Criteria

• Patients with prostate adenocarcinoma treated with radical prostatectomy;
• Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009,
only with Gleason score available;
• No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days)
without evidence of lymph node or distant metastases;
• PSA progression after prostatectomy defined as two consecutive rises with the
final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured
at least 6 weeks after radical prostatectomy;
• PSA at inclusion < 1.0 ng/mL;
• WHO performance status 0-2 at inclusion;
• Age at inclusion between 18 and 80 years;
• Written (signed and dated) informed consent prior to registration.

Exclusion Criteria

• Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
• Previous or concurrent active invasive cancers other than superficial
non-melanoma skin cancers;
• Patients with positive nodes or with distant metastases based on the surgical
specimen of lymphadenectomy or the following minimum diagnostic workup:
PSMA-PET/CT or PSMA-PET/MRI, 60 days prior to registration;
• Double-sided metallic hip prosthesis;
• Inability or unwillingness to understand the information on trial-related
topics, to give informed consent or to fill out QoL questionnaires.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the 5-year progression-free survival (PFS) after<br /><br>treatment.<br /><br>Progression is defined as biochemical progression, clinical progression,<br /><br>loco-regional or distant progression or start with hormonal therapy, whichever<br /><br>occurs first. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are: acute and late toxicity, Quality of Life (QoL),<br /><br>PCa-specific mortality, metastasis-free survival and overall survival at 5<br /><br>years.</p><br>