Evaluating the Impact of Prostate Only Versus Pelvic Radiation for N+ Prostate Cancer.

NCT02745587 | Terminated Phase 3

• 1 other identifier: 2016/0246
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

At least 40% of the patients with prostate cancer (PC) present with positive lymph nodes (N1). The optimal treatment strategy for these patients remains controversial. Although androgen deprivation therapy (ADT) is still often initiated as only treatment, the results are disappointing. Recent studies support the use of more aggressive therapies including external beam radiotherapy (EBRT) and ADT. The retrospective studies supporting the additional use of EBRT in N1 PC patients are however not conclusive regarding to the extent of radiation field. Even after an EPLND, there might be a role for pelvic EBRT in irradicating microscopic disease. However pelvic irradiation irrevocably results in increased toxicity. Moreover, in node negative (N0) PC patients the addition of pelvic EBRT has not resulted in improved outcome in randomised trials. However in the setting of Tumor Node Metastasis pathological stage (p)N1, proven on pathological examination, PC patients this has never been evaluated so far. This trial aims to answer the question whether or not pelvic EBRT is beneficial in pathological N1 PC patients. It is also important to realise that not all pathological N1 PC patients have similar outcome. There is a significant impact of number of positive lymph nodes on outcome, with two positive nodes being suggested as a significant cut-off value in predicting survival in pathological N1 PC patients. By stratifying the patients according to the number of lymph nodes involved this study will add to the proper selection of those patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no benefit of pelvic EBRT. Additionally, small RNAs constitute potentially valuable markers for the diagnosis, prognosis, and therapeutic choices in PC patients. Blood samples will be collected to examine the potential role of miRNAs as a biomarker and to develop a prognostic signature for clinical relapse-free survival. The results of this trial will serve as a base for developping new trials in order to optimise the treatment of patients with pathological N1 PC.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of number of participants without clinical relapse

  presence of loco(regional) release or distant metastases

  8 years

Secondary Outcomes (3)

• Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity

  5 years

• Assessment of number of participants experiencing Radiation Therapy Oncology Group toxicity

  10 years

• Assessment of number of participants with biochemical control

  8 years

Study Arms (2)

Prostate(bed) only

EXPERIMENTAL

external beam radiotherapy limited to the prostate(bed)

Radiation: radiotherapy

Prostate(bed) and pelvis

ACTIVE COMPARATOR

external beam radiotherapy to the prostate(bed) and pelvic lymph node regions

Radiation: radiotherapy

Interventions

radiotherapy RADIATION

high dose external beam radiotherapy limited to the prostate(bed)

Prostate(bed) and pelvis; Prostate(bed) only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proven carcinoma of the prostate
• Positive lymph nodes found on extended pelvic dissection (EPLND) defined as:
• Removal of the lymphatic tissue in the obturator fossa + along the external iliac vessels + additional complete resection of the lymph nodes (lnn) along, medially and laterally to, the hypogastric vessels
• If technically feasible: removal of lnn along the common iliac vessels
• Removal of ≥10 lnn
• Treatment of the primary tumor by either radical prostatectomy or EBRT
• Willing to receive androgen deprivation therapy
• World health organization 0-2
• Written informed consent

You may not qualify if:

• Prior pelvic irradiation
• Other primary tumor (except for non-melanoma skin tumors) diagnosed \<5 years before enrollment
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Valérie Fonteyne, Prof

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: September 22, 2022
• Last Updated: December 28, 2022

Record last verified: 2016-04

Locations

BE (1)