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

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ClinicalTrials.gov Identifier: NCT01962324
Recruitment Status : Active, not recruiting
First Posted : October 14, 2013
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Camilla Thellenberg Karlsson, Umeå University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Lymphatic Metastasis Radiation: SIB Dose-Escalation Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
Actual Study Start Date : March 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SIB Dose-Escalation radiotherapy
Simultaneous integrated boost to intraprostatatic tumor and lymph nodes
Radiation: SIB Dose-Escalation Radiotherapy



Primary Outcome Measures :
  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 Outcome Measures :
  1. Quality of Life [ Time Frame: 0,6,12,36,60 months ]
    Questionnaires distributed to patients at these time intervals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962324


Locations
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Sweden
Umeå University, Cancercenter
Umeå, Sweden, 90185
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Camilla Thellenberg Karlsson, MD Umea University
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Responsible Party: Camilla Thellenberg Karlsson, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01962324    
Other Study ID Numbers: PARAPLY-1
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Camilla Thellenberg Karlsson, Umeå University:
Quality of Life
Radiotherapy
Radiotherapy, dose-escalation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Lymphatic Metastasis
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases