NCT03141671

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

Active, enrolled Phase 2 Last updated 14 May 2024

What this trial tests

Phase 2 trial testing GnRH in Prostate Cancer in 345 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 November 2017

Primary endpoint
5 April 2025

31 December 2025

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	345
Start date	24 November 2017
Primary completion	5 April 2025
Estimated completion	31 December 2025
Sites	8 locations across United States

Drugs / interventions tested

• GnRH — full drug profile →
• Bicalutamide (bicalutamide) — full drug profile →
• Salvage radiation
• Abiraterone (ABIRATERONE) — full drug profile →
• Prednisone
• Apalutamide (apalutamide) — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

Adults 18 to 95, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research study is comparing two different combinations of androgen deprivation therapy (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy (prostate cancer).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biochemical recurrence in patients with prostate cancer after primary definitive therapy: treatment based on risk stratification.
   Shore ND, Moul JW, Pienta KJ, Czernin J, et al · · 2024 · cited 100× · PMID 37679602 · DOI 10.1038/s41391-023-00712-z
2. Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial.
   Tran PT, Lowe K, Tsai HL, Song DY, et al · · 2023 · cited 31× · PMID 36367998 · DOI 10.1200/jco.22.01662
3. Exploring anti-androgen therapies in hormone dependent prostate cancer and new therapeutic routes for castration resistant prostate cancer.
   Harris AE, Metzler VM, Lothion-Roy J, Varun D, et al · · 2022 · cited 30× · PMID 36263323 · DOI 10.3389/fendo.2022.1006101
4. Dermatological Adverse Events in Prostate Cancer Patients Treated with the Androgen Receptor Inhibitor Apalutamide.
   Pan A, Reingold RE, Zhao JL, Moy A, et al · · 2022 · cited 25× · PMID 35020444 · DOI 10.1097/ju.0000000000002425
5. The maximum standardized uptake value in patients with recurrent or persistent prostate cancer after radical prostatectomy and PSMA-PET-guided salvage radiotherapy-a multicenter retrospective analysis.
   Spohn SKB, Farolfi A, Schandeler S, Vogel MME, et al · · 2022 · cited 18× · PMID 35984452 · DOI 10.1007/s00259-022-05931-5
6. A Clinical Evaluation of Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer: Guiding Principles for Treatment Selection and Perspectives on Research.
   Laccetti AL, Morris MJ, Kantoff PW. · · 2020 · cited 8× · PMID 33402834 · DOI 10.2147/ott.s242921
7. Should androgen deprivation therapy and other systemic treatments be used in men with prostate cancer and a rising PSA post-local treatments?
   Patrikidou A, Zilli T, Baciarello G, Terisse S, et al · · 2021 · cited 7× · PMID 34707693 · DOI 10.1177/17588359211051870
8. Combining prostate cancer radiotherapy with therapies targeting the androgen receptor axis.
   Ghashghaei M, Kucharczyk M, Elakshar S, Muanza T, et al · · 2019 · cited 6× · PMID 31708657 · DOI 10.3747/co.26.5005