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Metastatic Hormone-sensitive Prostate CancerPhase 2/3NCT03879122

A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer

A Phase 2/3 study testing Ipilimumab 5 MG/ML, Nivolumab 10 MG/ML and Docetaxel in people with Metastatic Hormone-sensitive Prostate Cancer, run by Spanish Oncology Genito-Urinary Group at 30 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Metastatic prostate cancer is an incurable disease that typically spreads beyond the prostate. The standard of care is to systemically treat the disease with androgen deprivation therapy (ADT). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Ipilimumab 5 MG/ML, Nivolumab 10 MG/ML and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
30 sitesSpain
Study dates
11 Feb 2019to 31 Dec 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

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

  • Patients must be at least 18 years of age
  • Signed and dated written informed consent, obtained before the performance of any protocol-related procedure.
  • Histological or cytological diagnosis of prostate cancer with an elevated PSA level and radiologic evidence of metastatic disease.
  • ECOG performance-status score of 0, 1, or 2. Patients with a score of 2 are eligible if the decrement in functioning was due to prostate cancer.
  • Metastatic disease that has spread beyond the prostate or relapsed after local therapy, documented by body CT scan and/or bone scan, according to PCWG 3 criteria, with high volume according to criteria used in the CHAARTED study.
  • Radiological and scintigraphic studies to identify initial evaluable disease should be done as follows:
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  • If ADT has not been initiated, CT scans and bone scan must be obtained within 6 weeks prior to the start of ADT.
  • If all required imaging had not been completed prior to starting ADT, any additional scan must be obtained after starting androgen deprivation but prior to randomization and the initiation of docetaxel (It is assumed that the scans of patients with high volume disease would not normalize in less than 120 days to the point that a patient would go from "high volume" to "low volume").
  • Measurable or evaluable disease according to the PWGC 3.
  • Patients who started ADT for metastatic disease are eligible if ADT commenced within 120 days before randomization, they have not started docetaxel chemotherapy yet, and there was no evidence of clinical, radiological or biochemical progression after ADT.
  • Patients receiving ADT in the adjuvant and/or neoadjuvant setting for less than 30 months of therapy, AND the effect of the last depot injection had expired at least 12 months prior to documentation of metastatic disease, AND
  • They had no evidence of disease (PSA < 0.2 ng/dL) after prostatectomy plus hormonal therapy, or
  • PSA was < 0.5 ng/dL after completing radiation therapy plus adjuvant or neoadjuvant hormonal therapy, and had not doubled above nadir in at least 12 months.
  • Patients must have adequate organ function within 4 weeks prior to randomization and evidenced by:
  • Absolute Neutrophil Count > 1500/mm 3
  • Platelet count > 100,000/mm 3
  • Creatinine clearance (CrCl)> 30 mL/min calculated at screening using the Cockcroft- Gault formula: Creatinine clearance for mule (mL/min) = (140- age in years)(body weight in kg)/[72x(serum creatinine in mg/dl).
  • Total bilirubin < 1.5 ULN (< 3.0 mg/dl in patients with Gilbert´s Syndrome).
  • Prothrombin time or INR and PTT < 1.5 x ULN, except if on therapeutic anti- coagulation in which case the patient can be enrolled if stable and anti-coagulation levels are appropriate for their condition per good clinical practice.
  • ALT and AST < or = 3 x ULN (or < or = 5 if liver metastases)
  • At least 4 weeks should have passed after major surgery prior to randomization, and the patient should be recovered from all side effects and complications.
  • Men who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of treatment with study drug plus 5 half-lives of study drug plus 90 days (duration of sperm turnover) for a total of 31 weeks post-treatment completion.

Who cannot join

  • Patients are not eligible if the PSA has risen from its lowest point, between the beginning of androgen deprivation therapy and the date of randomization, and met criteria for progression as defined in the protocol.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, PROSTVAC, Sipuleucel-T or any previous immunotherapy or vaccines for cancer.
  • Prior chemotherapy in the adjuvant or neoadjuvant setting.
  • Unable to receive docetaxel at full doses at investigator criteria.
  • Peripheral neuropathy grade > 1.
  • All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia or fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to prior surgery or radiotherapy, which are not expected to resolve and result in long-term lasting sequelae, are permitted to enrol.
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  • History of hypersensitivity reaction to Docetaxel®, other drugs formulated with polysorbate 80, or monoclonal antibodies.
  • Prior hormone therapy or immunotherapy in the metastatic setting.
  • Prior palliative radiation therapy within 30 days of starting docetaxel.
  • Known acute or chronic HIV, Hepatitis B, or Hepatitis C. Past Hepatitis B infection with no signs of activity later, are allowed
  • Active brain metastases or leptomeningeal metastases, except if they have been treated and there is a magnetic resonance imaging (or CT scan if MRI were contraindicated) showing no evidence of progression for at least 4 weeks after the treatment
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days previous to randomization. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed.
  • Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous six months
  • History of malignancy in the past 5 years except for basal cell and squamous cell carcinoma of the skin and non-muscle-invasive bladder cancer. Other more malignancies considered to have a low potential to progress may be enrolled if approved by study chair.
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Participation in another clinical trial within 30 days prior to randomization.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Spain30 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital General de Ciudad Real

    Ciudad Real, 13005

  • Hospital General, Materno E Infantil Reina

    Córdoba, Cordoba, 14004

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Hestia Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón Y Cajal

    Madrid, 28013

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Sant Joan de Deu (Althaia Manresa)

    Manresa, Barcelona, 08242

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Sabadell

    Sabadell, Barcelona, 08208

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28072

  • Hospital Virgen Del Rocío

    Seville, 41013

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Hospital Virgen Macarena

    Seville, 41071

  • Hospital Virgen de La Salud

    Toledo, 45004

  • Hospital Arnau de Vilanova

    Valencia, Valenci, 46015

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

About this study

Official title: A Multi-arm, Multi-stage, Randomized Phase II/III Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer

Metastatic prostate cancer is an incurable disease that typically spreads beyond the prostate. The standard of care is to systemically treat the disease with androgen deprivation therapy (ADT). However, the disease progresses in virtually all patients to the state of castration resistant prostate cancer (CRPC), with a median time to progression of 24 months. Patients with high volume disease (with either visceral metastasis and/or bone metastasis) exhibit a worse prognosis, with a median clinical progression of 14 months.

Recently, the CHAARTED and STAMPEDE studies demonstrated that the combination of Docetaxel (chemotherapy) and ADT delayed the clinical progression and improved the survival a median of 14 months (17 for high volume patients). Nevertheless, the prognosis of patients with high volume metastatic disease continues to be poor.

Read more

Meanwhile the immunotherapy, the use of antibodies that recognize tumoral cells and promote the immune system activity against the cancer, has emerged as a very useful option in many cancers. Among others, the antibodies Nivolumab and Ipilimumab have been approved for the treatment of multiple types of cancer.

In this context, SOGUG (Spanish Oncology Genitourinary Group) has designed this new study "PROSTRATEGY" with the objective of evaluating whether the addition of immunotherapy to chemotherapy and ADT improves the prognosis and survival of patients with high volume metastatic hormone-sensitive prostate cancer.

Being tested
Ipilimumab 5 MG/ML, Nivolumab 10 MG/ML, Docetaxel, ADT (androgen deprivation therapy)
Keywords
prostate cancer, immunotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ipilimumab 5 MG/MLDrug

    Also called YERVOY

    Ipilimumab will be administered on day 1 of each cycle every 3 weeks. In arm 3, ipilimumab should be started at least 2 weeks but no later than 120 days after surgical castration or the first dose of LHRH analogue. Patients should receive 2 doses of ipilimumab (6 weeks). It will be followed, 3 weeks later, by 3 cycles of docetaxel and by 2 additional doses of ipilimumab and 3 more cycles of docetaxel. Four weeks later, Nivolumab will be administered on day 1 every 2 weeks until a maximum of 24 doses (48 weeks)

  • Nivolumab 10 MG/MLDrug

    Also called Opdivo

    Nivolumab will be administered every 2 weeks, until clinical progression or a maximum of 24 doses. Nivolumab should be started 4 weeks after the last dose of docetaxel, providing all the adverse effects have recovered, as if a new cycle of docetaxel were to be administered

  • DocetaxelDrug

    Docetaxel should be given on day 1 every 21 days, for up to 6 cycles (1 cycle = 21 days). Docetaxel should be started within 7 working days from the date of randomization in the arm 1 and 2.

    In arm 3, docetaxel will be given 3 weeks after the last dose of the previous treatment, providing all the side effects are grade ≤1.

  • ADT (androgen deprivation therapy)Drug

    Androgen deprivation therapy per the standard of care

Study groups in NCT03879122
Study groupRoleWhat they receive
ADT + DocetaxelActive comparatorADT (androgen deprivation therapy) plus 6 cycles of DOCETAXEL
Receives: Drug: Docetaxel; Drug: ADT (androgen deprivation therapy)
ADT + Docetaxel + NivolumabExperimentalADT (androgen deprivation therapy) plus DOCETAXEL plus NIVOLUMAB
Receives: Drug: Nivolumab 10 MG/ML; Drug: Docetaxel; Drug: ADT (androgen deprivation therapy)
ADT + Ipilimumab / Docetaxel + NivolumabExperimentalADT (androgen deprivation therapy) plus IPILIMUMAB alternating with DOCETAXEL and followed by NIVOLUMAB
Receives: Drug: Ipilimumab 5 MG/ML; Drug: Nivolumab 10 MG/ML; Drug: Docetaxel; Drug: ADT (androgen deprivation therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall Survival

    Measured: through study completion, an average of 2 years

Secondary outcomes (13)

  1. PSA response

    Measured: through study completion, an average of 2 years

  2. PSA progression-free survival (PSA-PFS)

    Measured: through study completion, an average of 2 years

  3. Radiological progression-free survival (rPFS)

    Measured: through study completion, an average of 2 years

  4. Clinical progression-free survival (cPFS)

    Measured: through study completion, an average of 2 years

  5. Time to castration resistant prostate cancer (TCRPC)

    Measured: through study completion, an average of 2 years

  6. Immune radiological progression-free survival (irPFS)

    Measured: through study completion, an average of 2 years

  7. Immune clinical progression-free survival (icPFS)

    Measured: through study completion, an average of 2 years

  8. Time to immune castration resistant prostate cancer (TiCRPC)

    Measured: through study completion, an average of 2 years

  9. Symptomatic skeletal-related event free survival (SSREFS)

    Measured: through study completion, an average of 2 years

  10. Toxicity of each of the treatment arms by assessing Adverse Events

    Measured: through study completion, an average of 2 years

  11. Quality of life (QOL)

    EQ-5D Questionnaire

    Measured: through study completion, an average of 2 years

  12. Quality of life (QOL)

    FACT-P Questionnaire

    Measured: through study completion, an average of 2 years

  13. Quality of life (QOL)

    BPI Questionnaire

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start11 Feb 2019
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-arm multi-stage (MAMS), multi-centre randomised controlled trial with 3 arms (2 experimental arms and a control arm) and 4 stages (three intermediate and a final stage). In all 3 intermediate stages of the trial, each experimental arm is compared in a pairwise manner with the control arm using an "intermediate" outcome measure. Experimental arms that do not reach a predefined critical value are discontinued. In the final stage, the remaining(s) arm(s) will be compared with the control arm in terms of overall survival (definitive outcome). The 3 arms included in this trial are the Control arm (ARM 1): ADT plus 6 cycles of DOCETAXEL and 2 experimental arms: ADT plus DOCETAXEL plus NIVOLUMAB (ARM 2) and ADT plus IPILIMUMAB alternating with DOCETAXEL and with NIVOLUMAB (ARM 3). Other experimental arms could be included later.
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879122
Sponsor's protocol ID
CA209-9HX
Status last verified
Oct 2022
First submitted
13 Mar 2019
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ipilimumab 5 MG/ML, Nivolumab 10 MG/ML and Docetaxel in people with Metastatic Hormone-sensitive Prostate Cancer, run by Spanish Oncology Genito-Urinary Group at 30 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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