Clinical trial NCT05373316: Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Official title: Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Neoplasm
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 95
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.

This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.


Eligibility criteria: Inclusion Criteria:

* Men aged 18 years or older with histologically proven prostate carcinoma
* Imaging stage T3b (as defined on mpMRI) N0M0
* Intraprostatic lesion visible on MRI
* Capable of giving informed consent

Exclusion Criteria:

* History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
* Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
* Absence of pre-treatment PSMA PET CT
* WHO performance score \> 2
* International Prostate Symptom Score ≥ 15
* PSA \> 30
* Prostate volume \>100c

Primary outcomes:
measure: Acute gastrointestinal and genitourinary toxicity
timeFrame: 90 days after start of treatment
Secondary outcomes:
measure: Late GI and GU toxicity (CTCAE v5.0)
timeFrame: from 90 days after start of treatment up to 5 years
measure: Quality of life
timeFrame: from baseline up to 5 years after completion of treatment
measure: Quality of life
timeFrame: from baseline up to 5 years after completion of treatment
measure: Biochemical disease free survival
timeFrame: up to 5 years after completion of treatment
measure: Overall survival
timeFrame: up to 5 years after completion of treatment
measure: Prostate cancer specific survival
timeFrame: up to 5 years after completion of treatment
measure: Distant metastasis free survival
timeFrame: up to 5 years after completion of treatment
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord Holland
Study officials:
References: