Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients

NCT03630666 | Active Not Recruiting

• 1 other identifier: ICO-N-2017-13
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 16

Brief Summary

Metastatic prostate cancer has traditionally been regarded as an incurable dissemination of disease, and treatment is focused on delaying progression rather than eliminating all tumor burden. Local therapies, and specifically radiotherapy, have been directed at quality of life endpoints and not at improving survival. However, advances in imaging and systemic therapy have identified a population of 'oligometastatic' patients who have a lower burden of metastatic disease (usually ≤5 lesions), who may present an exception. This condition is hypothesized to occupy the hinterland between incurable metastatic disease and locoregional disease, where micrometastatic disease is assumed to exist and yet remain eradicable. Oligometastases can be detected using standard imaging but the sensitivity of these exams is very low for patients with a PSA below 10 ng/ml. In France, FCH PET imaging is now routinely available in a large majority of cancer centres. More recently, PSMA PET imaging has been developed. Since most oligometastases are now discovered at a time when conventional imaging is unable to detect metastases, we must rely on the literature regarding purely biochemically-relapsing prostate cancer patients. Three strategies have been explored: (i) observation until symptoms develop, (ii) early intermittent Androgen Deprivation Therapy (IADT) and (iii) continuous Androgen Deprivation Therapy (ADT). Recent data suggest that, of the three strategies, early intermittent ADT was superior in term of overall survival to observation in controlling metastatic prostate cancer, and this effect was similar in the biochemically-relapsing prostate cancer patient population. This phase III study will explore the role of salvage pelvic IG-IMRT combined with intermittent ADT (IADT) in pelvic oligometastatic patients in prolonging the first failure-free interval between the first and the second intermittent ADT courses.

Conditions

Prostate Cancer; Oligometastasis

Keywords

Oligometastatic pelvic lymph nod, IADT, radiotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  PSA or CT scan

  90 months

Secondary Outcomes (5)

• overall survival

  90 months

• time to castration-resistance

  90 months

• toxicity to IADT and radiation

  90 months

• Quality of life during long-term treatment

  Up to 90 months after start of treatment

• site of tumor progression

  90 months

Study Arms (2)

IADT - Intermittent Androgen Deprivation Therapy

ACTIVE COMPARATOR

one injection of IADT. The overall duration of IADT will be six months.

Drug: IADT

IADT + Radiotherapy (Intermittent Androgen Deprivation Therapy plus Radiotherapy)

EXPERIMENTAL

One injection of IADT. The overall duration of IADT will be six months. Irradiation three months after injection of IADT. The overall duration of radiotherapy will be three months.

Combination Product: IADT + radiotherapy

Interventions

IADT DRUG

Patient will receive one injection of IADT at randomization

Also known as: LH-RH (Luteinizing Hormone Releasing Hormone) agonist

IADT - Intermittent Androgen Deprivation Therapy

IADT + radiotherapy COMBINATION_PRODUCT

Patient will receive one injection of IADT at randomization then will receive irradiation 3 months after injection of IADT

Also known as: IG-IMRT, LH-RH (Luteinizing Hormone Releasing Hormone) agonist

IADT + Radiotherapy (Intermittent Androgen Deprivation Therapy plus Radiotherapy)

Eligibility Criteria

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

You may qualify if:

• Histologically-proven prostate adenocarcinoma
• Age ≥ 18 years
• Performance Status 0-1
• Prior radical prostate treatment (surgery and/or radiotherapy)
• ≤ 5 metastatic pelvic lymph nodes detected by FCH-PET or PSMA-PET
• Upper limit of metastatic lymph nodes: aortic bifurcation
• Biochemical relapse (according to the European Association of Urology guidelines) is defined by :
• Following radical prostatectomy (RP), biochemical recurrence (BCR) is defined by two consecutive rising PSA values \> 0.20 ng/ml After primary radiation therapy (RT), the Radiation Therapy Oncology Group (RTOG) and American Society for Radiation Oncology Phoenix Consensus Conference definition of PSA failure is any PSA increase \> 2.00 ng/ml higher than the PSA nadir value, regardless of the serum concentration of the nadir.
• Having given written informed consent prior to any procedure related to the study.
• Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations.
• Patient has valid health insurance
• Subjects who have partners of childbearing potential must be willing to use a method of effective birth control during treatment and for 12 months following completion of treatment with ADT or IG-IMRT.

You may not qualify if:

• Bone or visceral metastases
• Para-aortic lymph node metastases (above the aortic bifurcation)
• Presence of more than five metastatic lymph nodes
• Evidence of local intra-prostatic relapse
• Evidence of prostate bed relapse in a previously irradiated region. Prostate bed relapses which have not been previously irradiated will not be excluded
• Evidence of metastasis at initial diagnosis
• Evidence of distant metastases beyond the pelvic lymph nodes
• Previous irradiation of pelvic lymph nodes
• Castration-resistant prostate cancer (CRPC) as defined by : a castrate serum testosterone \< 6 nmol/L (50 ng/L)
• Contraindications to pelvic irradiation (e.g. chronic inflammatory bowel disease)
• Contraindications to ADT (known hypersensitivity to any of the study drugs or excipients)
• Severe uncontrolled hypertension defined as systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
• Other malignancy treated within the last 5 years (except non-melanoma skin cancer)
• Patients with a biochemical relapse while on active treatment with LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, or oestrogen
• Treatment during the past month with products known to influence PSA levels (such as finasteride)

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Direction Générale de l'Offre de Soins: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (16)

Institut Sainte Catherine

Avignon, 84918, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHRU de Brest

Brest, 29200, France

Location

Clinique Pasteur

Brest, 29200, France

Location

Institut de Cancérologie de Bourgogne

Chalon-sur-Saône, 71100, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut de Cancérologie de Montpellier

Montpellier, 34298, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Institut de Cancérologie

Nantes, 44000, France

Location

Hopital Privé du Confluent

Nantes, 44277, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

ICL Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

Centre Saint Yves

Vannes, 56000, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; 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)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Officials

• STEPHANE SUPIOT, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: phase 3 study, randomised, open

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 15, 2018
• Study Start: December 4, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-07

Locations

FR (16)