Prostate Cancer Clinical Trial
— PARTOfficial title:
Phase II Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer Using Arc Therapy (IMAT/VMAT)
Prospective non-randomized phase 2 trial to study the efficacy of additional elective para-aortic RT (PART) in pN1 patients compared to those who were historically treated with adjuvant whole pelvic radiotherapy (WPRT) alone.
Status | Recruiting |
Enrollment | 137 |
Est. completion date | February 1, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent and willingness to comply with the treatment and follow-up - Diagnosis of histopathologically confirmed prostate cancer - No former treatment for prostate cancer - Presence of pN1 disease after ePLND (criteria defined in the protocol) - Age > 18 - Karnofsky Performance score > 70 - Ability to understand the informed consent (Helsinki Declaration) Exclusion Criteria: - Recurrent disease status - Presence of cM1a, cM1b or cM1c disease - Former radiotherapy making WPRT and/or PART impossible - Prior malignancy, not disease-free > 5 years, except basocellular skin epithelioma - Severe or active comorbidity likely to impact on the feasibility of WPRT and/or PART - Disorder precluding understanding of trial information |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical relapse-free survival (cRFS) | The absence of clinical relapse (cR) at biological imaging | Median follow-up of 60 months | |
Secondary | Acute toxicity | (CTCAE 4.0) | Median follow-up of 90 days | |
Secondary | Late toxicity | (CTCAE 4.0) | Median follow-up of 3 years | |
Secondary | Quality-of-life - General | EORTC QLQ-C30 | Median follow-up of 3 years | |
Secondary | Quality-of-life - Prostate specific | EORTC QLQ-PR25 | Median follow-up of 3 years | |
Secondary | Quality-of-life - Measure of health outcome | EQ-5D-5L | Median follow-up of 3 years | |
Secondary | Quality-of-life - Urinary incontinence | ICIQ-SF | Median follow-up of 3 years | |
Secondary | Quality-of-life - Erectile function | IIEF-5 | Median follow-up of 3 years | |
Secondary | Time to palliative ADT | Indications for palliative ADT or based on the EAU guidelines | Median follow-up of 5 years | |
Secondary | Time to castration-refractory prostate cancer (CRPC) | Criteria for CRPC as defined in the EAU guidelines | Median follow-up of 5 years | |
Secondary | Cause-specific survival | Cause-specific survival | Median follow-up of 5 years | |
Secondary | Overall survival | Overall survival | Median follow-up of 5 years | |
Secondary | In field pelvic disease control (at biological imaging) | In field pelvic disease control (PET-CT imaging (PSMA/choline) is performed in case of PSA progression) | Median follow-up of 5 years | |
Secondary | In field PA disease control (at biological imaging) | In field PA disease control (PET-CT imaging (PSMA/choline) is performed in case of PSA progression) | Median follow-up of 5 years |
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