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

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01903408

Klaus Tschira 00.153.2009

ARO 2009-05 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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199 participants in 5 patient groups

Arm 1: Boost to prostate

Other group

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

Treatment:

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

Arm 2: Boost to prostate and lymph node metastases

Other group

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

Treatment:

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

Arm 3: Boost to prostate bed

Other group

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

Treatment:

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

Arm 4: Boost to prostate bed and lymph node metastases

Other group

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

Treatment:

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

Arm 5: Boost to lymph node metastases

Other group

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

Treatment:

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