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

Prostate Cancer Clinical Trial

— PLATIN  

Official title:

Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903408
• Other study ID #: Klaus Tschira 00.153.2009
• Secondary ID: ARO 2009-05
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Est. completion date: May 2020

Study information

• Verified date: January 2023
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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)

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, University Hospital Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Klaus Tschira Stiftung gGmbH

Country where clinical trial is conducted

Germany, 

References & 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 — View 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. do — View 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. Fron — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biochemical recurrence free survival		2 years
Secondary	Quality of Life	Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30	2 years