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Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment (PLATIN)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically confirmed prostate cancer with Gleason Score
  • risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement
  • Karnofsky Index >/= 70%
  • age 18-75 years
  • neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy
  • written informed consent

Exclusion Criteria:

  • stage IV (distant metastases)
  • lymph node metastases outside the pelvis
  • rising prostate-specific antigen (PSA) under antihormonal treatment
  • severe wound complications after laparatomy
  • severe lymph edema of the legs, elephantiasis, postthrombotic syndrome
  • decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy
  • history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin)
  • previous irradiation of the pelvic lymph nodes
  • concurrent participation in a clinical trial that might influence the results of either trial

Sites / Locations

  • Department of Radiation Oncology, University Hospital Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Arm 1: Boost to prostate

Arm 2: Boost to prostate and lymph node metastases

Arm 3: Boost to prostate bed

Arm 4: Boost to prostate bed and lymph node metastases

Arm 5: Boost to lymph node metastases

Arm Description

IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate (76.5 Gy) in 34 fractions Arm finished recruitment and follow-up

IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate (76.5 Gy) & pelvic lymph node mets (61.2 Gy) in 34 Fx

IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate bed (68 Gy) in 34 fractions Arm finished recruitment and follow-up and is published

IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) & lymph node metastases (61.2 Gy) in 34 Fx

Patients with previous irradiation of the prostate bed: IMRT of the pelvic lymphatic drainage (46.8 Gy) above the previous treatment fields, SIB to lymph node metastases (63.2 Gy) in 26 Fx

Outcomes

Primary Outcome Measures

Rate of safe feasibility (SDR)
Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.

Secondary Outcome Measures

Biochemical recurrence free survival
Quality of Life
Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

Full Information

First Posted
July 16, 2013
Last Updated
January 31, 2023
Sponsor
Heidelberg University
Collaborators
Klaus Tschira Stiftung gGmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01903408
Brief Title
Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
Acronym
PLATIN
Official Title
Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 2009 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Klaus Tschira Stiftung gGmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.
Detailed Description
The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate. Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed. Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Boost to prostate
Arm Type
Other
Arm Description
IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate (76.5 Gy) in 34 fractions Arm finished recruitment and follow-up
Arm Title
Arm 2: Boost to prostate and lymph node metastases
Arm Type
Other
Arm Description
IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate (76.5 Gy) & pelvic lymph node mets (61.2 Gy) in 34 Fx
Arm Title
Arm 3: Boost to prostate bed
Arm Type
Other
Arm Description
IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate bed (68 Gy) in 34 fractions Arm finished recruitment and follow-up and is published
Arm Title
Arm 4: Boost to prostate bed and lymph node metastases
Arm Type
Other
Arm Description
IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) & lymph node metastases (61.2 Gy) in 34 Fx
Arm Title
Arm 5: Boost to lymph node metastases
Arm Type
Other
Arm Description
Patients with previous irradiation of the prostate bed: IMRT of the pelvic lymphatic drainage (46.8 Gy) above the previous treatment fields, SIB to lymph node metastases (63.2 Gy) in 26 Fx
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
Intervention Description
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Primary Outcome Measure Information:
Title
Rate of safe feasibility (SDR)
Description
Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Biochemical recurrence free survival
Time Frame
2 years
Title
Quality of Life
Description
Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically confirmed prostate cancer with Gleason Score risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement Karnofsky Index >/= 70% age 18-75 years neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy written informed consent Exclusion Criteria: stage IV (distant metastases) lymph node metastases outside the pelvis rising prostate-specific antigen (PSA) under antihormonal treatment severe wound complications after laparatomy severe lymph edema of the legs, elephantiasis, postthrombotic syndrome decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin) previous irradiation of the pelvic lymph nodes concurrent participation in a clinical trial that might influence the results of either trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Herfarth, Prof. Dr.
Organizational Affiliation
University Hospital Heidelberg, Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26547188
Citation
Habl G, Katayama S, Uhl M, Kessel KA, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial. BMC Cancer. 2015 Nov 7;15:868. doi: 10.1186/s12885-015-1886-5.
Results Reference
result
PubMed Identifier
24422782
Citation
Katayama S, Habl G, Kessel K, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with integrated boost to the prostate bed - initial results of the PLATIN 3 Trial. BMC Cancer. 2014 Jan 14;14:20. doi: 10.1186/1471-2407-14-20.
Results Reference
result
PubMed Identifier
31456941
Citation
Koerber SA, Winter E, Katayama S, Slynko A, Haefner MF, Uhl M, Sterzing F, Habl G, Schubert K, Debus J, Herfarth K. Elective Node Irradiation With Integrated Boost to the Prostate Using Helical IMRT-Clinical Outcome of the Prospective PLATIN-1 Trial. Front Oncol. 2019 Aug 13;9:751. doi: 10.3389/fonc.2019.00751. eCollection 2019.
Results Reference
result

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Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment

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