Prostate cancer

Project 1 Pro-Pro

Aim 

To describe a cohort of PC-pts. prospectively and consecutively treated with contemporary RT regarding treatment outcome, related morbidity and failure patterns. Furthermore, to model normal tissue complications probability (NTCP), and collection of biological material for future exploration of endogenous markers for radiosensitivity.

Methods 

Currently, PC-pts. are incomplete registered  in the national database regarding RT treatment details and PRO’s. The study will collect all relevant data from this PC-pts. cohort, including details of RT planning and treatment (WP12). Furthermore, systematic and validated PRO’s will be sampled for the treated PC-pts (WP7). Patients are followed regarding biochemical relapse, metastatic relapse, local relapse, and survival (progression free survival (PFS), cancer specific survival (CSS) and overall survival (OS)).

Expected results 

PRO’s and treatment plans from the cohort will facilitate modelling of NTCP. Failure patterns will be explored. Future exploration of endogenous markers for radio sensitivity (WP1).

Impact/Relevance/Ethics 

The study will enable us to better select PC-pts., who will benefit from the treatment and to identify factors relevant for treatment related morbidity and show the outcome of a modern treated patient cohort in terms of failure and treatment morbidity. The results will be used for future improvement of RT for PC and tailored/adapted RT.

Project 2 Prosalbra - NCT04231006

Aim  

To examine morbidity and efficacy of salvage brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after RT in a phase 2 study. Secondary aim: Assess the feasibility of salvage HDR BT performed as a focal treatment based on multiparametric (mp) MRI.

Methods

HDR BT will be offered as a single modality focal treatment to the site of recurrence within the prostate gland as identified by PSMA PET/CT and mpMRI. Endpoints are late morbidity assessed by PRO´s and uroflowmetry. Furthermore, failure patterns, PFS, CSS and OS.

Expected results

The study offers a curative treatment option to a patient cohort otherwise treated with palliative lifelong endocrine treatment. Minimal to moderate treatment-related morbidity is expected from careful patient selection and state of the art imaging techniques enabling a focal treatment strategy.

Impact/Relevance/Ethics

Focal HDR BT can be offered for a selected patient cohort and offer a platform for future standard treatment. The focal strategy can be applied in PC-pts cohorts referred to RT for improved outcome in terms of morbidity and local control.

Project 3 Oligo-Pro

Aim

To explore the effect of RT for PC-pts. with local/ locally advanced primary prostate cancer and asymptomatic oligometastatic disease to bones and/or lymph nodes in a phase 2 study. Current standard treatment for oligometastatic disease is palliative ADT. Data suggests that durable disease control can be achieved by local RT and SBRT to metastatic sites.

Methods

A non-randomised phase 2 study with ADT and RT to prostate and pelvic lymph nodes according to national standards. SBRT will be delivered to the metastatic sites (no more than 3 sites). The patients will be followed regarding biochemical relapse, metastatic relapse, local relapse, and PFS, CSS, OS. PRO’s will be collected.

Expected results

Morbidity will be studied with systematic and validated PRO’s collected WP7. Disease outcome and the pattern of failure will be explored.

Impact/Relevance/Ethics 

Currently, no curative intended treatment is offered to such patients. The study will show the outcome of local treatment for oligometastatic PC and may impact future treatment algorithms. Follow up will ensure that morbidity is closely followed.  

Project 4 PRO-proton - NCT05350475

Aim

To examine outcome and morbidity of proton therapy (PT) in locally advanced PC in comparison to standard RT. PT is not offered as a standard treatment for PC- pts. However, several pts. have received PT for localized PC, but there are no data showing real benefit regarding outcome and morbidity for PT in this patient category. Larger randomized trials are non-existing. For locally advanced PC-pts., PT might be more beneficial, since pelvic irradiation with high dose to the prostate is more toxic to the pelvic organs.

Methods

A phase 2 randomized study between RT (standard) and PT to the prostate and pelvic lymph nodes in combination with ADT. PRO’s and treatment plans will be collected and explored for NTCP modelling. The patients will be followed regarding biochemical relapse, metastatic relapse, local relapse, and survival (PFS, CSS, OS).

Expected results

The study will show the outcome and relevance of a new treatment for locally advanced PC in DK.  Follow up with validated PRO’s will ensure that patient morbidity is identified.

Impact/Relevance/Ethics

PT can be offered to PC-pts. in a randomized trial and provide a platform for future trials and standard treatment. Furthermore, to better select PC-pts. who will benefit from a more costly treatment with protons.