Long-term Better Than Short-term ADT With Salvage RT

NCT04242017 | Recruiting Phase 2

• 1 other identifier: S61996
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized, multicenter, prospective PHASE II trial to assess the effect of short- versus long-term adjuvant ADT with high dose salvage radiotherapy on distant metastasis free survival in case of biochemical relapse (BR) after radical prostatectomy.

Conditions

Prostate Cancer

Keywords

pN0; biochemical recurrence; salvage radiation therapy; hormonal treatment

Outcome Measures

Primary Outcomes (1)

• Metastasis-free survival

  Time to appearance of M1a-b-c disease. In order to assess the absence/presence of M1a-M1c disease as early as possible, top-of-the-line imaging will be conducted in case of BR during follow-up after SRT and after agreement of the multidisciplinary uro-oncology team. Time point zero is the last day of radiotherapy (also applies for secondary endpoints). Top of the line imaging includes: CT thorax abdomen and bone scintigraphy (standard). PSMA PET-CT is allowed but not obligatory. Patients who are also included in the diagnostic imaging study are required to receive a PSMA PET-CT. Whole body MRI is allowed but not obligatory. BR is defined as any rise in PSA above the level of 0.2 ng/ml after a postradiotherapy nadir or a continued rise in the serum PSA despite salvage treatment (3). In case a BR is not accompanied by metastatic progression, PSMA PET/CT will be repeated every 6 months or earlier in case of prostate cancer-related symptoms.

  5 years

Secondary Outcomes (11)

• Pelvic recurrence-free survival

  up to 10 years after randomization

• Clinical progression-free survival

  up to 10 years after randomization

• (Palliative) Systemic therapy-free survival

  up to 20 years (or more) after randomization

• Time to CRPC

  up to 20 years (or more) after randomization

• Cause-specific survival (CSS)

  up to 20 years (or more) after randomization

Study Arms (2)

salvage RT + 6 months ADT

ACTIVE COMPARATOR

70 Gy to the prostate bed (2 Gy/fraction) + 6 months ADT

Drug: Triptoreline

salvage RT + 24 months ADT

EXPERIMENTAL

70 Gy to the prostate bed (2 Gy/fraction) + 24 months ADT

Drug: Triptoreline

Interventions

Triptoreline DRUG

Comparison of the duration of ADT (Triptoreline)

salvage RT + 24 months ADT; salvage RT + 6 months ADT

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically proven prostate cancer, treated with RP and ePLND. All patients have to be pN0. The minimal template for ePLND is defined as the removal of the external iliac, internal iliac and obturator nodes (standard template). Removal of the presacral and common iliac nodes is left at the discretion of the treating urologist.
• Testosterone levels within above 150 ng/dl.
• ECOG 0-1
• Life expectancy more than 5 years
• Signed informed consent

You may not qualify if:

• Presence of pN1 disease at original surgical specimen.
• Presence of distant metastasis at time of referral (M1a-c). If PSA more than 0.4 ng/ml, imaging with PET-CT is required to rule out distant metastasis (see above). Other additional imaging modalities (CT scan, bone scintigraphy...) are allowed but left at the discretion of the treating centre.
• Undetectable PSA (less than 0.2 ng/ml) at time of referral.
• Previous RT making new RT impossible (overlapping treatment fields).
• Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia…)
• Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids…)
• Not able understanding treatment protocol or signing informed consent.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Ipsen: collaborator

Study Sites (3)

AZ Maria Middelares

Ghent, Belgium

RECRUITING

UZ Gent

Ghent, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Related Publications (1)

• Berghen C, Joniau S, Laenen A, Devos G, Rans K, Goffin K, Haustermans K, Meerleer G. Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial. Future Oncol. 2020 Sep;16(27):2035-2044. doi: 10.2217/fon-2020-0390. Epub 2020 Jul 15.

  PMID: 32666822 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

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)

Gonadotropin-Releasing Hormone; 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

Study Officials

• Gert De Meerleer, MD, PhD

  UZ Leuven

  STUDY CHAIR

Central Study Contacts

Charlien Berghen, MD

CONTACT

003216345217; charlien.berghen@uzleuven.be

Gert De Meerleer, MD, PhD

CONTACT

003216347600; gert.demeerleer@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: July 7, 2020
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)