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

NCT ID: NCT01962324

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2023-05-09

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Neoplasms Lymphatic Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SIB Dose-Escalation radiotherapy

Simultaneous integrated boost to intraprostatatic tumor and lymph nodes

Group Type EXPERIMENTAL

SIB Dose-Escalation Radiotherapy

Intervention Type RADIATION

Interventions

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SIB Dose-Escalation Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Camilla Thellenberg Karlsson

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camilla Thellenberg Karlsson, MD

Role: PRINCIPAL_INVESTIGATOR

Umea University

Locations

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Umeå University, Cancercenter

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PARAPLY-1

Identifier Type: -

Identifier Source: org_study_id

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