Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer (PARAPLY-1)

Umeå University

Status: Completed

Conditions: Lymphatic Metastasis; Prostatic Neoplasms

Treatments: Radiation: SIB Dose-Escalation Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01962324

PARAPLY-1

Details and patient eligibility

About

A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.

Enrollment: 85 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed high risk prostate cancer with a risk of lymphatic spread >15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
• Written informed consent
• > 18 years
• Fiducial gold markers implanted in the prostate (min 3)

Exclusion criteria

• • Non MR-safe implants or other contraindication to MRI

  • WHO PS>1
  • Previous pelvic irradiation
  • TURP within 6 months
  • IPSS >19
  • Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
  • Creatinin clearance < 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

SIB Dose-Escalation radiotherapy

Experimental group

Description:

Simultaneous integrated boost to intraprostatatic tumor and lymph nodes

Treatment:

Radiation: SIB Dose-Escalation Radiotherapy