NCT01903408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

9 years

First QC Date

July 16, 2013

Last Update Submit

January 31, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (2)

  • Biochemical recurrence free survival

    2 years

  • Quality of Life

    2 years

Study Arms (5)

Arm 1: Boost to prostate

OTHER

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

Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB

Arm 2: Boost to prostate and lymph node metastases

OTHER

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

Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB

Arm 3: Boost to prostate bed

OTHER

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

Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB

Arm 4: Boost to prostate bed and lymph node metastases

OTHER

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

Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB

Arm 5: Boost to lymph node metastases

OTHER

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

Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB

Interventions

Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBRADIATION

The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)

Arm 1: Boost to prostateArm 2: Boost to prostate and lymph node metastasesArm 3: Boost to prostate bedArm 4: Boost to prostate bed and lymph node metastasesArm 5: Boost to lymph node metastases

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (3)

  • 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.

    PMID: 26547188RESULT

  • 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.

    PMID: 24422782RESULT

  • 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.

    PMID: 31456941RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Klaus Herfarth, Prof. Dr.

    University Hospital Heidelberg, Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 19, 2013

Study Start

May 1, 2009

Primary Completion

May 1, 2018

Study Completion

May 1, 2020

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

DE(1)