Skip to main content
OpenTrials
Completed

NCT Number: NCT01962324

Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lymphatic Metastasis Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University, Cancercenter

Umeå, 90185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SIB Dose-Escalation Radiotherapy

Radiation

Primary outcomes

  1. PSA progression free survival

    Time frame: 36 months

    PSA progression defined according to American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix definition: nadir PSA + 2 ng/mL (on three consecutive measurements with at least one month between each)

Secondary outcomes

  1. Genitourinary Quality of Life

    Time frame: 0 6 12 36 60 months

    Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe

  2. Gastrointestinal Quality of Life

    Time frame: 0 6 12 36 60 months

    Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe

  3. Overall Quality of Life

    Time frame: 0 6 12 36 60 months

    Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe

  4. Sexual Quality of Life

    Time frame: 0 6 12 36 60 months

    Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV

Acronym: PARAPLY-1

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2013
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.