Prostate CancerOLIGOPELVIS2NCT03630666
Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients
A study testing IADT and IADT + radiotherapy in people with Prostate Cancer and Oligometastasis, run by Institut Cancerologie de l'Ouest at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Oligometastasis
- What is being tested?
- IADT and IADT + radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 16 sitesFrance
- Study dates
- 4 Dec 2018to Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- If ADT has been previously administered to the patient, at least 12 months must have elapsed between the predicted duration of the last injection and inclusion of the patient in the study. For this category of patients, serum testosterone must be higher than 6 nmol/L (50 ng/L) prior to inclusion
- 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.
Who cannot join
- 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
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- 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)
- In case of previous prostate/prostate bed radiotherapy, PET-positive lymph nodes have to be located outside the previous irradiation field with a maximum of 20 Gy to the PET-positive lymph nodes region
- Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
- Disorder precluding understanding of trial information or informed consent
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Institut Sainte Catherine
Avignon, 84918
Institut Bergonie
Bordeaux, 33076
CHRU de Brest
Brest, 29200
Clinique Pasteur
Brest, 29200
Institut de Cancérologie de Bourgogne
Chalon-sur-Saône, 71100
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69373
Institut de Cancérologie de Montpellier
Montpellier, 34298
Centre Azureen de Cancerologie
Mougins, 06250
Institut de Cancérologie
Nantes, 44000
Hopital Privé du Confluent
Nantes, 44277
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44600
ICL Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
Centre Saint Yves
Vannes, 56000
About this study
Official title: A Study Comparing Intermittent Androgen Depriving Therapy With Or Without Salvage High-Dose Intensity Modulation Radiotherapy (IG-IMRT)To Oligometastatic Pelvic Lymph Nodes In Biochemically-relapsing Prostate Cancer Patients.
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.
Read the detailed description
Screening procedures will be performed up to three months before starting IADT. After obtaining informed consent, patients will be randomly allocated to one of two groups:
Experimental group: IADT + IG-IMRT Control group: IADT
In both study arms, the first injection of IADT will be administered in hospital on the day of randomization. The overall duration of IADT will be six months.
In the experimental group, patients will receive radiotherapy three months after the first injection of IADT.
The overall duration of radiotherapy will be three months.
The overall duration of IADT will be six months. It will be administered three months, +/- 15 days prior to the first day of radiotherapy. At the completion of the six-month treatment period, a non-treatment interval will start if :
there is no evidence of clinical disease progression and the PSA level is ≤ 4.00 ng/ml If the PSA subsequently rises above 0.20 ng/ml and is confirmed by a second measurement at least three weeks later, PET/CT imaging will be repeated every 6 months until a clinical failure is detected or until the PSA rises above 4.00 ng/ml.
- Conditions
- Prostate Cancer, Oligometastasis
- Being tested
- IADT, IADT + radiotherapy
- Keywords
- Oligometastatic pelvic lymph nod, IADT, radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IADTDrug
Also called LH-RH (Luteinizing Hormone Releasing Hormone) agonist
Patient will receive one injection of IADT at randomization
IADT + radiotherapyCombination product
Also called IG-IMRT, LH-RH (Luteinizing Hormone Releasing Hormone) agonist
Patient will receive one injection of IADT at randomization then will receive irradiation 3 months after injection of IADT
| Study group | Role | What they receive |
|---|---|---|
| IADT - Intermittent Androgen Deprivation Therapy | Active comparator | one injection of IADT. The overall duration of IADT will be six months. Receives: 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. Receives: Combination Product: IADT + radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
PSA or CT scan
Measured: 90 months
Secondary outcomes (5)
overall survival
death
Measured: 90 months
time to castration-resistance
serum testosterone mesure
Measured: 90 months
toxicity to IADT and radiation
evaluation with NCI-CTC AE v4.03
Measured: 90 months
Quality of life during long-term treatment
Quality of life will be assessed every 3 months using the EORTC QLQ-C30 and the prostate cancer-specific module QLQ-PR25. These validated questionnaires evaluate physical, emotional, and social functioning, as well as symptoms related to prostate cancer and its treatment.
Measured: Up to 90 months after start of treatment
site of tumor progression
FCH or PSMA PET at biochemical relapse
Measured: 90 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start4 Dec 2018
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- phase 3 study, randomised, open
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- STEPHANE SUPIOT, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630666
- Sponsor's protocol ID
- ICO-N-2017-13
- Acronym
- OLIGOPELVIS2
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2018
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Josset Q, Blanc-Lapierre A, Pigne G, Cartier L, Pasquier D, Ronchin P, Bera G, Hasbini A, Schipman B, Khalifa J, Sargos P, Quivrin M, Schick U, Mallet F, Laude C, Morand C, Loos G, Vaugier L, Zhou K, Mesgouez-Nebout N, Supiot S. Study Protocol of OLIGOPELVIS 2-GETUG P12: A Randomized Phase 3 Study Comparing Intermittent Androgen-deprivation Therapy with or Without Salvage High-dose Intensity-modulated Radiotherapy to Oligorecurrent Pelvic and Para-aortic Lymph Nodes in Patients with Biochemically Relapsing Prostate Cancer. Eur Urol Oncol. 2026 Jun 11:S2588-9311(26)00113-6. doi: 10.1016/j.euo.2026.04.009. Online ahead of print.
PubMed 42276876Corda H, Blanc-Lapierre A, Pigne G, Cartier L, Pasquier D, Ronchin P, Bera G, Hasbini A, Schipman B, Khalifa J, Sargos P, Quivrin M, Schick U, Mallet F, Laude C, Morand C, Loos G, Vaugier L, Mesgouez-Nebout N, Supiot S. OLIGOPELVIS 2-GETUG P12- elective nodal radiotherapy for oligorecurrent pelvic/para-aortic nodes in prostate cancer: early toxicity of a randomized phase 3 trial. Radiother Oncol. 2026 Jul;220:111533. doi: 10.1016/j.radonc.2026.111533. Epub 2026 May 15.
PubMed 42140755