RecruitingNot ApplicableNCT06204341

Towards Optimal Treatment for High Risk Prostate Cancer

Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour


Sponsor

Haaglanden Medical Centre

Enrollment

207 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

Interventions

RADIATIONHYPOPRIME treatment

Hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy


Locations(1)

Haaglanden Medical Centre

Leidschendam, South Holland, Netherlands

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NCT06204341


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