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

Prostatic Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962324
• Other study ID #: PARAPLY-1
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 9, 2023

Study information

• Verified date: February 2024
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphatic Metastasis
• Prostatic Neoplasms

Intervention

Radiation:
• SIB Dose-Escalation Radiotherapy

Locations

Country	Name	City	State
Sweden	Umeå University, Cancercenter	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 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	0 6 12 36 60 months
Secondary	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 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	0 6 12 36 60 months
Secondary	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 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	0 6 12 36 60 months
Secondary	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 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	0 6 12 36 60 months