Oligometastatic Prostate Cancer (OMPC)Phase 3PSMA-DCNCT05939414
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
A Phase 3 study testing AAA617, piflufolastat (18F) and gallium (68Ga) gozetotide (25μg) in people with Oligometastatic Prostate Cancer (OMPC), run by Novartis Pharmaceuticals at 144 sites in 27 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer (OMPC)
- What is being tested?
- AAA617, piflufolastat (18F) and gallium (68Ga) gozetotide (25μg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 144 sitesin 27 countries
- Study dates
- 12 Mar 2024to 3 Oct 2031
- Phase
- Phase 3
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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate cancer prior to randomization
- Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam Radiation Therapy (EBRT), (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence (BCR) is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA > 0.2 ng/mL and rising post RP (with or without post-operation Radiation Therapy (RT))
- Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC. For definition of PSMA PET positivity, please refer to Section 8.1 and the Imaging Manual. Metastatic lesions may include regional/pelvic lymph nodes (N1), distant lymph nodes (M1a), bone (M1b), lung and others visceral (M1c) except liver and brain classified using American Joint Committee on Cancer (AJCC) 8. When counting the number of oligometastatic lesions, each lesion is counted as distinct metastasis irrespective of its anatomical location (e.g., one pelvic and one extra-pelvic lymph node will be counted as two metastatic lesions)
- At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET/CT information should be used
- Participants must have a negative CI for M1 disease at screening.
- Note:
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- For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions). For CI assessments, bone lesions must be assessed by bone scan only and soft tissue lesions must be assessed by CT/MRI scans only at screening.
- Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity. Two different readers will be involved, one reader for PSMA PET/CT scan and one reader for CI: Reader will be blinded to PSMA PET scan results while reading CI scans. Reader should not modify their assessment of CI scans (e.g. changing a lesion previously identified as equivocal in CI to unequivocal) after reading the PSMA PET scan. Similarly, biopsy positivity should not influence the reader in the assessment of CI positivity. More details on the reading paradigm will be provided in the imaging charter
- MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans
- Participants with pelvic disease (N1) seen in CI are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease)
- Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis is not exclusionary irrespective of PSMA PET positivity.
- If a previously surgically removed lesion was unequivocal for M1 by bone scan or CT, the participant is not eligible.
- All metastatic lesions detected at screening must be amenable to SBRT
- Non-castration testosterone level >100 ng/dL at screening
Who cannot join
- Participants with de novo OMPC at screening
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed
- Prior therapy with:
- ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment
- Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. ARPI's as a term includes both contemporary androgen synthesis inhibitors (e.g., abiraterone, galeterone, and orteneronel), and receptor inhibitors (enzalutamide, apalutamide and darolutamide).
- Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was terminated
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- ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy.
- Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant/neoadjuvant therapy are eligible provided that they discontinued therapy ≥3 months prior to randomization.
- Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants)
- Other hormonal therapy. e.g.,
- •Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization.
- Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy)
- Immunotherapy (e.g., sipuleucel-T)
- Chemotherapy, except if administered in the adjuvant/neoadjuvant setting completed > 12 months before randomization
- Any other investigational or systemic agents for metastatic disease
- Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization
- Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy or investigational therapy
- Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease/treatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
- Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Pointe
- Participants in immediate need of ADT or other systemic therapy as assessed by the investigator. In addition, investigators should only enroll participants who are committed to delay castration in accordance with the scope of the study and are willing to wait to start systemic therapy until distant progression (MFS event) as assessed by CI (consisting with existing treatment guidelines) and confirmed by BIRC is reached. This must be discussed with the participants before ICF is signed.
- Other protocol defined Inclusion/Exclusion may apply.
Trial locations and contacts
144 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
144 sites in 27 countries
United States39 sites, 36 recruiting
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30318
Sharon Joseph
Adam Nowlan
- Recruiting
University of Maryland Medical Ctr
Baltimore, Maryland, 21201
Dawn Barth, 410-328-8667, Dawn.Barth@umm.edu
Arif Hussain
- Recruiting
Johns Hopkins Kimmel Com Cancer Ctr
Baltimore, Maryland, 21231
Dana Kaplan, dkaplin1@jhmi.edu
Ana Kiess
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Courtney Hill, 225-215-1353, chill@marybird.com
Victor Lin
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Sinead Christensen, smchristensen@bwh.harvard.edu
Mai Anh Huynh
- Recruiting
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
Katerina von Helms, kvonhelm@bidmc.harvard.edu
David J Einstein
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Ashley Page, 773-702-8582, apage99@bsd.uchicago.edu
Mohammad Atiq
- Recruiting
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
Amy Rowell, 214-645-5905, Amy.Rowell@UTSouthwestern.edu
Kevin Courtney
- Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Jennifer Hege, 303-338-4876, jennifer.hege@usoncology.com
Allen Cohn
- Recruiting
Unity Point Clinic
Des Moines, Iowa, 50323
Missy Stravers, mstravers@iora.org
Mark Kellerman
- Recruiting
Rio Grande Urology
El Paso, Texas, 79912
Paola Delgado, pdelgado@riograndeurology.com
Jameson T Mendel
- Recruiting
The Cancer Institute of Alexian Brothers
Elk Grove, Illinois, 60007
Khalada Ahmad, khalada.ahmad@ascension.org
- Recruiting
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Evan Hubbard, +1 479 878 7098, EHubbard@hogonc.com
Joseph Thaddeus Beck
- Withdrawn
BAMF Health
Grand Rapids, Michigan, 49503
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Kaleigh Nunley, 252-744-0456, nunleyk16@ecu.edu
Andrew Ju
- Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Bhaloo Desai, Bhaloo.Desai@CSNF.us
Richard Cassidy
- Recruiting
University of Kansas Hospital
Kansas City, Kansas, 66160
Daniel Rivera, drivera3@kumc.edu
Xinglei Shen
- Recruiting
Dayton Physicians
Kettering, Ohio, 45409
Lynette Tipton, 937-771-2287, Lynette.Tipton@StatResearch.com
Trevor Bluemel
- Recruiting
VA Greater LA Healthcare System
Los Angeles, California, 90073
Samantha Tran, 310-478-3711, Samantha.Tran@va.gov
Matthew Rettig
- Recruiting
East Jefferson Hospital
Metairie, Louisiana, 70006
Alexandra Lieberman, alexandra.lieberman@lcmchealth.org
Alton Oliver Sartor
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Rebecca Floyd, 843-839-1679, rebecca.floyd@startresearch.com
Neal D Shore
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Laura Diedrich, laura.diedrich@vumc.org
Kerry Schaffer
- Recruiting
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
Viktoria Matessi, 212-639-3854, matessiv@mskcc.org
Daniel Gorovets
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Amber Ingram, 757-466-8683, amber.ingram@usoncology.com
Mark Fleming
- Recruiting
The Urology Center PC DBA UroHealth Partners
Omaha, Nebraska, 68114
Amy Nelson, anelson@urohealthpartners.com
Andrew Trainer
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304-1207
Niko Del Mar, 650-493-5000, niko.delmar@va.gov
Minal Vasanawala
- Recruiting
Stanford University
Palo Alto, California, 94304
Camellia Djebroun, 605-498-6000, cdjebrou@stanford.edu
Hilary Bagshaw
- Recruiting
Woodlands Medical Specialists
Pensacola, Florida, 32503
Jacqueline Martin, jacqueline.martin@woodlandsmed.com
Michael Poiesz
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Takeru Walleser, 507-538-2155, Walleser.Takeru@mayo.edu
Ryan Phillips
- Withdrawn
Profound Research LLC
Royal Oak, Michigan, 48073
- Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Jennifer Murray, 248-551-6485, jennifer.murray@corewellhealth.org
Andrew Thompson
- Recruiting
UCSF
San Francisco, California, 94115
Francim Aguilar, 415-514-6241, francim.aguilar@ucsf.edu
Steven Seyedin
- Recruiting
Oregon Urology Institute
Springfield, Oregon, 97477
Victoria Evans, 541-284-5508, vevans@oregonurology.com
Bryan Mehlhaff
- Recruiting
St Louis University
St Louis, Missouri, 63104
Sabrina Abdullaeva, sabrina.abdullaeva@health.slu.edu
Medhat Osman
- Withdrawn
VA St Louis Health Care System
St Louis, Missouri, 63106
- Recruiting
Wash U School of Medicine
St Louis, Missouri, 63110
Collin Welch, c.welch@wustl.edu
Hiram Gay
- Recruiting
Associated Med Professionals of NY
Syracuse, New York, 13210
Alex Bart, abart1@nj-urology.com
Steven Finkelstein
- Recruiting
Montefiore Hospital
The Bronx, New York, 10467-2490
Darciann O Sullivan, 267-455-2717, dosulli@montefiore.org
Benjamin A Gartrell
- Recruiting
Blue Ridge Cancer Center
Wytheville, Virginia, 24382
Tessa Blair, tessa.blair@usoncology.com
David Buck
Japan11 sites, 11 recruiting
- Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
- Recruiting
Novartis Investigative Site
Fukuoka, 8110213
- Recruiting
Novartis Investigative Site
Fukuoka, 8120033
- Recruiting
Novartis Investigative Site
Fukuoka, 8128582
- Recruiting
Novartis Investigative Site
Fukushima, 9601295
- Recruiting
Novartis Investigative Site
Ishikawa, 9208641
- Recruiting
Novartis Investigative Site
Kashiwa, Chiba, 2778577
- Recruiting
Novartis Investigative Site
Kobe, Hyōgo, 6500047
- Recruiting
Novartis Investigative Site
Kyoto, 6068507
- Recruiting
Novartis Investigative Site
Sapporo, Hokkaido, 0608648
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 2360004
Spain9 sites, 9 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, Catalonia, 08025
- Recruiting
Novartis Investigative Site
Barcelona, 08036
- Recruiting
Novartis Investigative Site
El Palmar, Murcia, 30120
- Recruiting
Novartis Investigative Site
Granada, Andalusia, 18014
- Recruiting
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Novartis Investigative Site
Madrid, 28040
- Recruiting
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Seville, 41013
- Recruiting
Novartis Investigative Site
Valencia, 46010
Canada8 sites, 8 recruiting
- Recruiting
Novartis Investigative Site
Calgary, Alberta, T2N 5G2
- Recruiting
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
- Recruiting
Novartis Investigative Site
London, Ontario, N6A 4G5
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
- Recruiting
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
- Recruiting
Novartis Investigative Site
Québec, Quebec, G1J 1Z4
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Germany8 sites, 8 recruiting
- Recruiting
Novartis Investigative Site
Aachen, 52074
- Recruiting
Novartis Investigative Site
Augsburg, 86179
- Recruiting
Novartis Investigative Site
Berlin, 10249
- Recruiting
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
- Recruiting
Novartis Investigative Site
Essen, 45147
- Recruiting
Novartis Investigative Site
Munich, Bavaria, 81377
- Recruiting
Novartis Investigative Site
Münster, 48149
- Recruiting
Novartis Investigative Site
Rostock, 18057
Italy8 sites, 7 recruiting
- Withdrawn
Novartis Investigative Site
Brescia, BS, 25123
- Recruiting
Novartis Investigative Site
Cona, FE, 44124
- Recruiting
Novartis Investigative Site
Genova, GE, 16132
- Recruiting
Novartis Investigative Site
Milan, MI, 20141
- Recruiting
Novartis Investigative Site
Negrar, VR, 37024
- Recruiting
Novartis Investigative Site
Pisa, PI, 56126
- Recruiting
Novartis Investigative Site
Roma, RM, 00168
- Recruiting
Novartis Investigative Site
Rozzano, MI, 20089
France6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Bordeaux, 33076
- Recruiting
Novartis Investigative Site
Bron, 69677
- Recruiting
Novartis Investigative Site
Clermont-Ferrand, 63011
- Recruiting
Novartis Investigative Site
Rouen, 76038
- Recruiting
Novartis Investigative Site
Saint-Cloud, Hauts De Seine, 92210
- Recruiting
Novartis Investigative Site
Saint-Herblain, 44805
Israel5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Beersheba, 8457108
- Recruiting
Novartis Investigative Site
Haifa, 3109601
- Recruiting
Novartis Investigative Site
Jerusalem, 9112001
- Recruiting
Novartis Investigative Site
Petah Tikva, 4941492
- Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
United Kingdom5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Bristol, Avon, BS2 8ED
- Recruiting
Novartis Investigative Site
Coventry, CV2 2DX
- Recruiting
Novartis Investigative Site
Guildford, Surrey, GU2 7XX
- Recruiting
Novartis Investigative Site
London, NW3 2QG
- Recruiting
Novartis Investigative Site
London, SW3 6JJ
Australia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Adelaide, South Australia, 5000
- Recruiting
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
- Recruiting
Novartis Investigative Site
Herston, Queensland, 4029
- Recruiting
Novartis Investigative Site
Malvern, Victoria, 3144
Slovakia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Bratislava, 833 10
- Recruiting
Novartis Investigative Site
Košice, 041 91
- Recruiting
Novartis Investigative Site
Nitra, 949 01
- Recruiting
Novartis Investigative Site
Trenčín, 911 01
Taiwan4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Taipei, 10002
- Recruiting
Novartis Investigative Site
Taipei, 103616
- Recruiting
Novartis Investigative Site
Taipei, 11217
- Recruiting
Novartis Investigative Site
Taoyuan, 33305
Argentina3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Caba, C1431FWO
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1426ANZ
- Recruiting
Novartis Investigative Site
CABA, C1181ACH
Belgium3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Aalst, 9300
- Recruiting
Novartis Investigative Site
Ghent, 9000
- Recruiting
Novartis Investigative Site
Wilrijk, 2610
China3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100036
- Recruiting
Novartis Investigative Site
Guangzhou, 510060
- Recruiting
Novartis Investigative Site
Shanghai, 200001
Czechia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Olomouc, 779 00
- Recruiting
Novartis Investigative Site
Ostrava, Poruba, 708 52
- Recruiting
Novartis Investigative Site
Prague, 150 06
Hungary3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Budapest, 1083
- Recruiting
Novartis Investigative Site
Budapest, 1122
- Recruiting
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Switzerland3 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Geneva, 1211
- Completed
Novartis Investigative Site
Lucerne, 6006
- Recruiting
Novartis Investigative Site
Zurich, 8063
Austria2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Linz, 4020
- Recruiting
Novartis Investigative Site
Vienna, 1090
Colombia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bogota, Cundinamarca, 110111
- Recruiting
Novartis Investigative Site
Bogotá, 110131
Greece2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Athens, 115 28
- Recruiting
Novartis Investigative Site
Thessaloniki, 540 07
Malaysia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kuala Lumpur, 59100
- Recruiting
Novartis Investigative Site
Petaling Jaya, Selangor, 46050
Mexico2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Huxquilucan, 52763
- Recruiting
Novartis Investigative Site
Mexico City, Mexico City, 14050
Singapore2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Singapore, 119074
- Recruiting
Novartis Investigative Site
Singapore, 168583
Brazil1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
São Paulo, São Paulo, 01246-000
Netherlands1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Amsterdam, 1066 CX
Puerto Rico1 site, 1 recruiting
- Recruiting
VA Caribbean Healthcare System
San Juan, 00921
Sara Fuentes-Medina, +17876417582#10393, Sara.Fuentes-Medina@va.gov
Bartolo Santiago-Delgado
About this study
Official title: An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
Read the detailed description
All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as [68Ga]Ga-PSMA-11) or piflufolastat (18F) ( also known as[18F]DCFPyL) PET/CT scan and CI (i.e., CT/MRI and bone scans).
Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved.
Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation.
- The duration of SBRT procedures is approximately 3 weeks.
- For participants randomized to the investigational arm (AAA617), the treatment duration will be up to 4 cycles of AAA617. For participants randomized to the control arm (observation) the treatment duration will end at the last fraction of SBRT administration.
- The visit frequency will be every week 1 and 3 of each of the 4 cycles and every 16 weeks thereafter (for both arms) until first event of disease progression (RECIST 1.1)
- The study duration is approximately 7.5 years.
- Conditions
- Oligometastatic Prostate Cancer (OMPC)
- Being tested
- AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg)
- Keywords
- Lutetium (177Lu) vipivotide tetraxetan, Oligometastatic Prostate Cancer (OMPC), Metastasis Free Survival (MFS), gallium (68Ga) gozetotide, piflufolastat (18F), prostate-specific membrane antigen (PSMA), Delay Castration, Stereotactic Body Radiation Therapy (SBRT), metastasis-directed therapy, Androgen Deprivation Therapy (ADT)-free survival.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA617Drug
Also called (177Lu) vipivotide tetraxetan
Radiopharmaceutical solution for infusion/injection
piflufolastat (18F)Drug
Provided as ready-to-use radiopharmaceutical
gallium (68Ga) gozetotide (25μg)Drug
Provided as PSMA-11 Kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm: lutetium (177Lu) vipivotide tetraxetan (AAA617) | Experimental | All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by a dose of 7.4 GBq (200 mCi) +/- 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for a planned 4 cycles. Receives: Drug: AAA617; Drug: piflufolastat (18F); Drug: gallium (68Ga) gozetotide (25μg) |
| Control arm: observation (watchful waiting) | No intervention | All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by observation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) is defined as the time from randomization to first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) and bone scans) as assessed by BIRC using RECIST 1.1 or death due to any cause, whichever occurs first.
Participants who are alive without distant metastasis at the analysis data cut-off or are lost to follow-up at the time of analysis will be censored for MFS at the time of their last adequate radiographic assessment. Clinical deterioration without objective radiographic evidence will not be considered as documented distant metastasis.
Measured: From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months
Secondary outcomes (15)
Key secondary endpoint: Time to Hormonal Therapy (TTHT)
Time to Hormonal Therapy (TTHT) is defined as the time from randomization to the time to Androgen Deprivation Therapy (ADT). The type of hormonal therapy will be at the discretion of the Investigator.
Measured: From date of randomization until date of Androgen Deprivation Therapy (ADT), assessed up to approximately 74 months
Investigator assessed Metastasis Free Survival (MFS)
Investigator assessed Metastasis Free Survival (MFS) is defined as the time from randomization to the first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., CT/MRI and bone scans) as assessed by Investigator using RECIST 1.1 or death from any cause, whichever occurs first.
Measured: From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 74 months
Time to prostate specific antigen (PSA) progression (TTPSAP)
Time to prostate specific antigen (PSA) progression (TTPSAP) is defined as time from randomization to first PSA progression 1. First PSA progression 1 is defined as a rising PSA confirmed on repeated measurement at least 3 weeks later, and at least greater than 25% and >= 2 ng/mL above nadir or baseline, whichever is lower. In the absence of PSA progression, TTPSAP will be censored at the last PSA measurement.
Measured: From date of randomization until date of first PSA progression, assessed up to approximately 74 months
Radiographic Progression Free Survival (rPFS)
Radiographic progression free survival (rPFS) is defined as the time from randomization to first documentation of confirmed radiographic progressive disease or death due to any cause (whichever occurs first) by conventional imaging (i.e., CT/MRI and bone scans) using RECIST 1.1. The rPFS will be analyzed based on BIRC and Investigator assessments respectively.
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 74 months
Time to next therapy (local or systemic)
Time to next therapy (local or systemic) is defined as the time from randomization to initiation of the next line of therapy (local or systemic). Next-line therapy is defined as the first new (local or systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EOT) reason.
Measured: From date of randomization until initiation of the next line of therapy (local or systemic), assessed up to approximately 74 months
24-month prostate-specific antigen (PSA) progression free survival (PFS)
24-month PSA PFS is defined as PSA PFS at 24 months. PSA PFS is defined as the time from date of randomization to the date of first documented PSA progression 2 or death from any cause, whichever occurs first. PSA progression 2 is defined as a PSA concentration above the nadir (or baseline if lower) of >= 0.5 ng/mL, confirmed by repeated measurement at least 3 weeks later. PSA PFS will be censored if no PSA PFS event is observed before the first to occur analysis cut-off date. The censoring date will be the date of the last adequate tumor assessment prior to cut-off.
Measured: From date of randomization until date of first documented PSA progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months
Time to symptomatic progression
Time to symptomatic progression is defined as time from randomization to the date of first documented event for any of the following, whichever occurs first: development of symptomatic skeletal event, escalation in cancer-related pain or worsening of disease-related symptoms leading to the initiation of a new systemic anticancer therapy, development of clinically significant symptoms due to local or regional tumor progression leading to surgery or radiation therapy.
Measured: From date of randomization until date of first documented symptomatic progression, assessed up to approximately 74 months
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
Measured: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) Questionnaire
The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies.
The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
Measured: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.
Measured: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Measured: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Time to First Symptomatic Skeletal Event (TTSE)
Time to first symptomatic skeletal event (TTSSE) is defined as date of randomization to the date of first new SSE or death from any cause, whichever occurs first. Symptomatic skeletal events (SSE) will be defined by the occurrence of any of the following (whichever occurs earlier): symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain.
Measured: From date of randomization till end of treatment (EOT) or death, whichever happens first, assessed up to approximately 74 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Dose modifications and intensity for AAA617
Dose modifications (dose interruptions and reductions) and dose intensity for AAA617 will be assessed and summarized using descriptive statistics.
Measured: From date of randomization until end of treatment (EOT), assessed up to approximately 30 months
Overall survival (OS)
Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. OS time for participants who are alive at the end of the study or are lost to follow-up will be censored at the date of last contact.
Measured: From date of randomization until date of death from any cause, assessed up to approximately 74 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start12 Mar 2024
- Primary completion25 Apr 2028 (estimated)
- Study completion3 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate Cancer (OMPC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939414
- Sponsor's protocol ID
- CAAA617D12302
- Other IDs
- 2022-502956-29-00
- Acronym
- PSMA-DC
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com