NCT07498959

Brief Summary

The goal of this prospective observational study is to learn about the short- and long-term effects of treating men over the age of 18 with good prognosis metastatic testicular cancer with either primary retropertioneal lymph node dissection, RPLND, (for low-stage metastastic seminoma) or three doses of chemotherapy for metastastic seminoma or nonseminoma. The main question it aims to answer is: Does primary RPLND lower the risk of side-effects compared to receiving chemotherapy?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
70mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Mar 2032

First Submitted

Initial submission to the registry

March 17, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2032

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

March 17, 2026

Last Update Submit

March 24, 2026

Conditions

Testicular CancerSeminomaQuality of LifeDe-escalationRPLND

Keywords

testicular cancerseminomaprimary RPLND

Outcome Measures

Primary Outcomes (1)

  • HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26

    Changes across study-groups in global HRQOL after treatment as measured by the EORTC QLQ-C30 with the testicular cancer-specific supplement EORTC QLQ-TC26 The QLQ-C30 comprises both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    2 years

Secondary Outcomes (5)

  • Fatigue after RPLND vs. chemotherapy

    2 years

  • Ejaculation problems

    2 years

  • Treatment related complications

    2 years

  • Healt economy

    2 years

  • PFS

    10 years

Study Arms (2)

Surgery group

ACTIVE COMPARATOR

Undergoing primary RPLND

Procedure: primary RPLND for low-stage metasatatic seminoma

Chemotherapy group

ACTIVE COMPARATOR

Receiving chemotherapy

Drug: 3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)

Interventions

3 courses of chemotherapy; Blemocin, Etoposide and Platinum (BEP)DRUG

systemic tretament for good prognosis metastastic testicular cancer

Also known as: Systemic chemotherapy, Bleomycin, Etoposide, Platinum
Chemotherapy group
primary RPLND for low-stage metasatatic seminomaPROCEDURE

surgical lymph node dissection

Surgery group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years undergoing an open or minimally invasive primary retroperitoneal lymph node dissection (RPLND) due to seminoma stage II A/B (maximum 2 nodes, \<30 mm in any dimension)
  • Patients undergoing an open or minimally invasive primary RPLND due to a retroperitoneal relapse of seminoma (maximum 2 nodes, \<30 mm in any dimension)
  • Patients ≥18 years scheduled for 3-4 courses of chemotherapy due to a newly diagnosed good-prognosis metastatic germ cell tumor (nonseminoma or seminoma)

You may not qualify if:

  • Previous chemotherapy (including adjuvant chemotherapy at diagnosis)
  • Previous RPLND
  • Practical considerations, such as not being able to read and sign informed consent or understand the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Göteborg, 413 45, Sweden

RECRUITING

Related Publications (7)

  • Thor A, Negaard HFS, Grenabo Bergdahl A, Almas B, Melsen Larsen S, Lundgren PO, Gerdtsson A, Halvorsen D, Johannsdottir B, Jansson AK, Hellstrom M, Wahlqvist R, Langberg CW, Hedlund A, Akre O, Glimelius I, Stahl O, Haugnes HS, Cohn-Cedermark G, Kjellman A, Tandstad T. Primary Retroperitoneal Lymph Node Dissection as Treatment for Low-volume Metastatic Seminoma in a Population-based Cohort: The Swedish Norwegian Testicular Cancer Group Experience. Eur Urol Open Sci. 2024 Jun 11;65:13-19. doi: 10.1016/j.euros.2024.05.006. eCollection 2024 Jul.

    PMID: 38966804BACKGROUND

  • Hiester A, Che Y, Lusch A, Kuss O, Niegisch G, Lorch A, Arsov C, Albers P. Phase 2 Single-arm Trial of Primary Retroperitoneal Lymph Node Dissection in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B (PRIMETEST). Eur Urol. 2023 Jul;84(1):25-31. doi: 10.1016/j.eururo.2022.10.021. Epub 2022 Nov 10.

    PMID: 36372627BACKGROUND

  • Matulewicz RS, Benfante N, Funt SA, Feldman DR, Carver B, Doudt A, Knezevic A, Sheinfeld J. Primary Retroperitoneal Lymph Node Dissection for Seminoma Metastatic to the Retroperitoneum. J Urol. 2024 Jan;211(1):80-89. doi: 10.1097/JU.0000000000003697. Epub 2023 Sep 6.

    PMID: 37672753BACKGROUND

  • Heidenreich A, Paffenholz P, Hartmann F, Seelemeyer F, Pfister D. Retroperitoneal Lymph Node Dissection in Clinical Stage IIA/B Metastatic Seminoma: Results of the COlogne Trial of Retroperitoneal Lymphadenectomy In Metastatic Seminoma (COTRIMS). Eur Urol Oncol. 2024 Feb;7(1):122-127. doi: 10.1016/j.euo.2023.06.004. Epub 2023 Jul 10.

    PMID: 37438222BACKGROUND

  • Grenabo Bergdahl A, Mansson M, Holmberg G, Fovaeus M. Robotic retroperitoneal lymph node dissection for testicular cancer at a national referral centre. BJUI Compass. 2022 Mar 31;3(5):363-370. doi: 10.1002/bco2.149. eCollection 2022 Sep.

    PMID: 35950045BACKGROUND

  • Daneshmand S, Cary C, Masterson T, Einhorn L, Adra N, Boorjian SA, Kollmannsberger C, Schuckman A, So A, Black P, Bagrodia A, Skinner E, Alemozaffar M, Brand T, Eggener S, Pierorazio P, Stratton K, Nappi L, Nichols C, Luo C, Li M, Hu B. Surgery in Early Metastatic Seminoma: A Phase II Trial of Retroperitoneal Lymph Node Dissection for Testicular Seminoma With Limited Retroperitoneal Lymphadenopathy. J Clin Oncol. 2023 Jun 1;41(16):3009-3018. doi: 10.1200/JCO.22.00624. Epub 2023 Mar 13.

    PMID: 36913642BACKGROUND

  • Hellesnes R, Myklebust TA, Fossa SD, Bremnes RM, Karlsdottir A, Kvammen O, Tandstad T, Wilsgaard T, Negaard HFS, Haugnes HS. Testicular Cancer in the Cisplatin Era: Causes of Death and Mortality Rates in a Population-Based Cohort. J Clin Oncol. 2021 Nov 10;39(32):3561-3573. doi: 10.1200/JCO.21.00637. Epub 2021 Aug 13.

    PMID: 34388002BACKGROUND

Related Links

MeSH Terms

Conditions

Testicular NeoplasmsSeminoma

Interventions

EtoposidePlatinumNeoadjuvant TherapyBleomycin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersGerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsCombined Modality TherapyTherapeuticsGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urologist, Associate Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 27, 2026

Study Start

March 19, 2026

Primary Completion (Estimated)

March 25, 2031

Study Completion (Estimated)

March 25, 2032

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Beginning 3 months and ending 3 years after the publication of results
Access Criteria
Other researchers interested in a collaboration can contact SWENOTECA via PI Anna Grenabo Bergdahl (anna.grenabo@vgregion.se) or head of SWENOTECA Torgrim Tandstad (torgrimtandstad@gmail.com). A data sharing agreement must be signed, and documents can be submitted via e-mail to the above-mentioned contacts.

Locations

SE(1)