Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer
PARAPLY-1
Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2023
CompletedMarch 1, 2024
February 1, 2024
8.2 years
October 9, 2013
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
36 months
Secondary Outcomes (4)
Genitourinary Quality of Life
0 6 12 36 60 months
Gastrointestinal Quality of Life
0 6 12 36 60 months
Overall Quality of Life
0 6 12 36 60 months
Sexual Quality of Life
0 6 12 36 60 months
Study Arms (1)
SIB Dose-Escalation radiotherapy
EXPERIMENTALSimultaneous integrated boost to intraprostatatic tumor and lymph nodes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Umeå University, Cancercenter
Umeå, 90185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Thellenberg Karlsson, MD
Umea University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 9, 2013
First Posted
October 14, 2013
Study Start
March 1, 2015
Primary Completion
May 9, 2023
Study Completion
May 9, 2023
Last Updated
March 1, 2024
Record last verified: 2024-02