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

• ClinicalTrials.gov Identifier: NCT01903408
• Recruitment Status: Unknown
• First Posted: July 19, 2013
• Last Update Posted: October 17, 2018
• Sponsor: Heidelberg University
• Collaborator: Klaus Tschira Stiftung gGmbH
• Information provided by (Responsible Party): Klaus Herfarth, MD, Heidelberg University

Tracking Information

• First Submitted Date: July 16, 2013
• First Posted Date: July 19, 2013
• Last Update Posted Date: October 17, 2018
• Actual Study Start Date: May 2009
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 18, 2013)

Rate of safe feasibility (SDR) [ Time Frame: 2 years ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 18, 2013)

• Biochemical recurrence free survival [ Time Frame: 2 years ]
• Quality of Life [ Time Frame: 2 years ]
  Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
• Official Title: Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

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

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

Study Arms

• Arm 1: Boost to prostate
  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
  Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
• Arm 2: Boost to prostate and lymph node metastases
  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
  Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
• Arm 3: Boost to prostate bed
  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
  Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
• Arm 4: Boost to prostate bed and lymph node metastases
  IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) & lymph node metastases (61.2 Gy) in 34 Fx
  Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
• Arm 5: Boost to lymph node metastases
  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: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 13, 2018): 199
• Original Estimated Enrollment (submitted: July 18, 2013): 200
• Estimated Study Completion Date: May 2020
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 2 Years to 5 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01903408
• Other Study ID Numbers: Klaus Tschira 00.153.2009; ARO 2009-05 ( Registry Identifier: ARO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Klaus Herfarth, MD, Heidelberg University
• Study Sponsor: Heidelberg University
• Collaborators: Klaus Tschira Stiftung gGmbH

Investigators

• Principal Investigator: Klaus Herfarth, Prof. Dr.; University Hospital Heidelberg, Department of Radiation Oncology

• PRS Account: Heidelberg University
• Verification Date: October 2018