Clinical trial NCT06204341: Towards Optimal Treatment for High Risk Prostate Cancer
Official title: Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk Prostate Carcinoma
Keywords: hypo fractionation
elective lymph node irradiation
focal boost
androgen deprivation therapy reduction
Lead sponsor: Haaglanden Medical Centre
Sponsor class: OTHER
Collaborators: name: Tata Memorial Centre
First posted: 2024-01-12
Enrollment: 207
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments.

* patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation)
* the tumor will get a higher dose
* androgen deprivation therapy will be reduced as much al possible preventing side effects

Researchers will compare oncological outcome and toxicity.

Detailed description: Rationale: Recently several randomized trial have shown benefits of changes made to radiotherapy of (high risk) localized prostate cancer patients: A focal boost was shown to improve outcome in men with intermediate/high risk prostate cancer (FLAME trial). Elective lymph node irradiation was shown to improve outcome in high risk prostate cancer patients (POP-RT). (Extreme) hypo fractionation was shown to be safe for low/intermediate risk prostate cancer patients. In addition: the added benefit of ADT (with substantial toxicity) seems reduced with improvements made to treatment and diagnosis in recent years (DART 01/05); own recent work on this topic; to be published)). None off the above were combined into one ideal treatment for high risk prostate cancer.

Objective: Determine the safety (oncological outcome and toxicity) of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer.

Study design: prospective cohort study with matched contemporary control group Study population: Men with high risk prostate cancer with an indication for elective lymph node irradiation Intervention: hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate Main study parameters/endpoints: biochemical recurrence free survival and late toxicity Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The additional burden of the study is considered to be low, as additional tests or site visits in comparison to current clinical follow up are not planned. Regarding safety, different parts of the investigational treatment were already shown to be safe in previous studies. The current study aims to combine these different parts into one treatment. We estimate that the risks associated with combining these treatments are very limited.

Eligibility criteria: Inclusion Criteria:

* Men (aged ≥18 years of age) diagnosed within 6 months before inclusion with high risk prostate cancer:

  * T3 based on digital rectal examination AND/OR
  * Grade \>= 4 AND/OR
  * PSA \>=20 ug/L
* Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)

Exclusion Criteria:

* Prior pelvic radiotherapy
* TransUrethral Resection of the Prostate (TURP) \< 3 months ago
* Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc)
* contraindications to MRI
* no visible lesion on MRI in prostate for boost
* no PSMA-PET scan
* inflammatory bowel disease
* metastatic disease (M1)
* PSA \>50
* unsuitable for SBRT or WPRT
* medical history of cancer other than basal cell carcinoma of the skin

Primary outcomes:
measure: Biochemical recurrence free survival
timeFrame: 5 years
measure: Late gastrointestinal and genito-urinary toxicity, and erectile dysfunction
timeFrame: at 6 months and 2 years
Secondary outcomes:
measure: Metastasis free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Pattern of failure
timeFrame: 5 years
Other outcomes:
Locations:
city: Leidschendam
country: Netherlands
facility: Haaglanden Medical Centre
state: Zuid Holland
Study officials:
affiliation: Haaglanden Medical Centre
name: Leonard P Bokhorst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: