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

• Sponsor: Umeå University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01962324
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 92.1
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms; Lymphatic Metastasis	Radiation: SIB Dose-Escalation Radiotherapy	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2015
• Anticipated Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. PSA progression free survival [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 [0,6,12,36,60 months]

   Questionnaires distributed to patients at these time intervals

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Umeå University, Cancercenter	Umeå		Sweden	90185

Sponsors and Collaborators

• Umeå University

Investigators

• Principal Investigator: Camilla Thellenberg Karlsson, MD, Umea University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Camilla Thellenberg Karlsson, MD, PhD, Umeå University
• ClinicalTrials.gov Identifier: NCT01962324
• Other Study ID Numbers: PARAPLY-1
• First Posted: Oct 14, 2013
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Camilla Thellenberg Karlsson, MD, PhD, Umeå University: Quality of Life; Radiotherapy; Radiotherapy, dose-escalation
• Additional relevant MeSH terms: Prostatic Neoplasms; Lymphatic Metastasis

Study Results

No Results Posted as of Aug 28, 2019