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

Primary Purpose

Prostatic Neoplasms, Lymphatic Metastasis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SIB Dose-Escalation Radiotherapy
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Quality of Life, Radiotherapy, Radiotherapy, dose-escalation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Umeå University, Cancercenter

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIB Dose-Escalation radiotherapy

Arm Description

Simultaneous integrated boost to intraprostatatic tumor and lymph nodes

Outcomes

Primary Outcome Measures

PSA progression free survival
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

Genitourinary Quality of Life
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
Gastrointestinal Quality of Life
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
Overall Quality of Life
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
Sexual Quality of Life
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

Full Information

First Posted
October 9, 2013
Last Updated
May 9, 2023
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01962324
Brief Title
Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer
Acronym
PARAPLY-1
Official Title
Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Lymphatic Metastasis
Keywords
Quality of Life, Radiotherapy, Radiotherapy, dose-escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIB Dose-Escalation radiotherapy
Arm Type
Experimental
Arm Description
Simultaneous integrated boost to intraprostatatic tumor and lymph nodes
Intervention Type
Radiation
Intervention Name(s)
SIB Dose-Escalation Radiotherapy
Primary Outcome Measure Information:
Title
PSA progression free survival
Description
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)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Genitourinary Quality of Life
Description
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
Time Frame
0 6 12 36 60 months
Title
Gastrointestinal Quality of Life
Description
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
Time Frame
0 6 12 36 60 months
Title
Overall Quality of Life
Description
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
Time Frame
0 6 12 36 60 months
Title
Sexual Quality of Life
Description
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
Time Frame
0 6 12 36 60 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Thellenberg Karlsson, MD
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umeå University, Cancercenter
City
Umeå
ZIP/Postal Code
90185
Country
Sweden

12. IPD Sharing Statement

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

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