Abstract 3312
Background
Salvage radiotherapy (SRT) is a potentially curative option for patients with rising PSA (biochemical recurrence) after radical prostatectomy. Recently, success rates of SRT were significantly improved through the use of concomitant anti-androgen (AAT) or androgen-deprivation (ADT) therapy. In RTOG 96-01, 2 years of bicalutamide 150 mg resulted in a 5% OS benefit at 12-years. In GETUG-AFU 16, 5-year progression-free survival was significantly improved when SRT was combined with 6 months of an LHRH agonist. Based on GETUG-AFU 16, most European urologists and (radiation) oncologists now combine SRT with at least 6 months of ADT. However, ADT comes with several serious side-effects, both physical (cardiovascular, metabolic, musculoskeletal) and psychological (sexual, emotional and cognitive). Considering RTOG 96-01, and in view of new AAT options, it appears worthwhile to look for alternatives. In that respect, apalutamide (ERLEADA®), a next-generation anti-androgen, is an interesting candidate.
Trial design
This is a phase II randomized, open-label study comparing SRT in combination with 6 months of LHRH (ant)agonist (arm A) versus 6 cycles of apalutamide 240 mg daily (each cycle is 28 +/- 2 days) (arm B) in hormone-naïve patients with biochemical recurrence (PSA > 0.1 µg/L at least 8 weeks after radical prostatectomy). Patients with severe erectile dysfunction are excluded. All subjects will receive SRT as standard of care and will be randomly assigned in a 1:1 ratio to arm A or B. Primary objective is to compare sexual function, based on the EPIC-26 sexual domain score, at 9 months (i.e. 3 months after the end of hormonal treatment). Secondary endpoints include general quality of life (EPIC-26, EORTC QLQ C30 and PR25, FACT-P), acute as well as late toxicity (CTCAE version 5.0), and PSA (complete) response rates (i.e. decline from baseline in PSA level of 80% (90%) or greater). The trial was approved by the local ethics committee on April 2nd 2019 and started recruiting immediately thereafter.
Clinical trial identification
NCT03899077; 2018-004365-13.
Editorial acknowledgement
Legal entity responsible for the study
GZA Hospitals.
Funding
Janssen.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3073 - 1 patient 3 different advance Ca nurse’s roles: symptom management&continuum care through a joint approach in a clinical case
Presenter: Catarina Almeida
Session: Poster Display session 3
Resources:
Abstract
4527 - Identification of malnutrition risk factors in patients with cancer in the first nursing visit
Presenter: Amaia Valverde
Session: Poster Display session 3
Resources:
Abstract
2904 - Engaging Cancer Survivors, Healthcare Providers and Advocates in The Development of a Colorectal Cancer Survivorship Information Resource: A Participatory Action Research Study
Presenter: Amanda Drury
Session: Poster Display session 3
Resources:
Abstract
3435 - Medical nurses’ experiences of the care-needs of adult patients with a primary brain tumour
Presenter: Jamila Mohammed
Session: Poster Display session 3
Resources:
Abstract
857 - Feasibility and acceptability of a mHealth intervention to increase colonoscopy uptake among Chinese first-degree relatives: a pilot cluster randomized controlled trial
Presenter: Yang Bai
Session: Poster Display session 3
Resources:
Abstract
1087 - Cancer patient participation and compliance in microbiome sample collection: an oncology research nurse’s experience
Presenter: Julie Malo
Session: Poster Display session 3
Resources:
Abstract
2783 - Implementing Digital Individual Care plans for Patients with Head and Neck cancer- Challenges and opportunities
Presenter: Helena Ullgren
Session: Poster Display session 3
Resources:
Abstract
1152 - The Effect of the Short-term and Long-term Compassion Fatigue Resiliency Program on the Quality of Life, Perceived Stress and Psychological Resilience of Oncology-Hematology Nurses
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
1172 - Competing risk analyses of overall survival and cancer-specific survival in patients with orbital rhabdomyosarcoma after surgery: a large cohort study
Presenter: Yu Zhang
Session: Poster Display session 3
Resources:
Abstract
5949 - Communication of genetic information to family members in hereditary cancers and healthcare providers’ role
Presenter: Carla Pedrazzani
Session: Poster Display session 3
Resources:
Abstract