Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial

J Janssen; F H E Staal; C L Brouwer; J A Langendijk; I J de Jong; R J A van Moorselaar; E Schuit; J F Verzijlbergen; R J Smeenk; S Aluwini

doi:10.1186/s12885-022-09523-2

Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial

J Janssen^*, F H E Staal, C L Brouwer, J A Langendijk, I J de Jong, R J A van Moorselaar, E Schuit, J F Verzijlbergen, R J Smeenk, S Aluwini

^*Corresponding author for this work

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Abstract

BACKGROUND: More than 60% of oligo-recurrent prostate cancer (PCa) patients treated with metastasis-directed radiotherapy (MDRT) develop biochemical recurrence within 2 years. This recurrence rate emphasises the need for improved treatment and patient selection. In line with the treatment of primary PCa, the efficacy of MDRT may be enhanced when combined with androgen-deprivation therapy (ADT). Furthermore, the availability of PSMA PET/CT offers an excellent tool for optimal patient selection for MDRT. This phase III randomised controlled trial will investigate the role of the addition of ADT to MDRT in oligo-recurrent PCa patients selected with PSMA PET/CT to enhance oncological outcome.

METHODS: Two hundred and eighty patients will be randomised in a 1:1 ratio to the standard treatment arm (MDRT alone) or the experimental arm (MDRT + 6 months ADT). Patients with biochemical recurrence after primary treatment of PCa presenting with ≤ 4 metastases will be included. The primary endpoint is the 2.5-year metastases progression-free survival (MPFS). Secondary endpoints are acute and late toxicity, quality of life, biochemical progression-free survival, overall survival, and the sensitivity of the PSMA PET/CT for detecting oligometastases at low PSA-levels. So far, between March 2020 and December 2021, one hundred patients have been included.

DISCUSSION: This phase III randomised controlled trial will assess the possible benefit of the addition of 6 months ADT to MDRT on metastases progression-free survival, toxicity, QoL and survival in PCa patients with 1-4 recurrent oligometastatic lesions.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT04302454 . Registered 10 March 2020.

Original language	English
Article number	482
Number of pages	8
Journal	BMC Cancer
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s12885-022-09523-2
Publication status	Published - 2-May-2022

Keywords

Androgen Antagonists/therapeutic use
Androgens
Chronic Disease
Clinical Trials, Phase III as Topic
Humans
Male
Neoplasm Recurrence, Local/drug therapy
Positron Emission Tomography Computed Tomography
Prostatic Neoplasms/drug therapy
Quality of Life
Randomized Controlled Trials as Topic

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Janssen, J., Staal, F. H. E., Brouwer, C. L., Langendijk, J. A., de Jong, I. J., van Moorselaar, R. J. A., Schuit, E., Verzijlbergen, J. F., Smeenk, R. J., & Aluwini, S. (2022). Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial. BMC Cancer, 22(1), Article 482. https://doi.org/10.1186/s12885-022-09523-2

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title = "Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial",

abstract = "BACKGROUND: More than 60% of oligo-recurrent prostate cancer (PCa) patients treated with metastasis-directed radiotherapy (MDRT) develop biochemical recurrence within 2 years. This recurrence rate emphasises the need for improved treatment and patient selection. In line with the treatment of primary PCa, the efficacy of MDRT may be enhanced when combined with androgen-deprivation therapy (ADT). Furthermore, the availability of PSMA PET/CT offers an excellent tool for optimal patient selection for MDRT. This phase III randomised controlled trial will investigate the role of the addition of ADT to MDRT in oligo-recurrent PCa patients selected with PSMA PET/CT to enhance oncological outcome.METHODS: Two hundred and eighty patients will be randomised in a 1:1 ratio to the standard treatment arm (MDRT alone) or the experimental arm (MDRT + 6 months ADT). Patients with biochemical recurrence after primary treatment of PCa presenting with ≤ 4 metastases will be included. The primary endpoint is the 2.5-year metastases progression-free survival (MPFS). Secondary endpoints are acute and late toxicity, quality of life, biochemical progression-free survival, overall survival, and the sensitivity of the PSMA PET/CT for detecting oligometastases at low PSA-levels. So far, between March 2020 and December 2021, one hundred patients have been included.DISCUSSION: This phase III randomised controlled trial will assess the possible benefit of the addition of 6 months ADT to MDRT on metastases progression-free survival, toxicity, QoL and survival in PCa patients with 1-4 recurrent oligometastatic lesions.TRIAL REGISTRATION: ClinicalTrials.gov, NCT04302454 . Registered 10 March 2020.",

keywords = "Androgen Antagonists/therapeutic use, Androgens, Chronic Disease, Clinical Trials, Phase III as Topic, Humans, Male, Neoplasm Recurrence, Local/drug therapy, Positron Emission Tomography Computed Tomography, Prostatic Neoplasms/drug therapy, Quality of Life, Randomized Controlled Trials as Topic",

author = "J Janssen and Staal, {F H E} and Brouwer, {C L} and Langendijk, {J A} and {de Jong}, {I J} and {van Moorselaar}, {R J A} and E Schuit and Verzijlbergen, {J F} and Smeenk, {R J} and S Aluwini",

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year = "2022",

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doi = "10.1186/s12885-022-09523-2",

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journal = "BMC Cancer",

issn = "1471-2407",

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number = "1",

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Janssen, J , Staal, FHE , Brouwer, CL , Langendijk, JA , de Jong, IJ, van Moorselaar, RJA, Schuit, E, Verzijlbergen, JF, Smeenk, RJ & Aluwini, S 2022, 'Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial', BMC Cancer, vol. 22, no. 1, 482. https://doi.org/10.1186/s12885-022-09523-2

TY - JOUR

T1 - Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT)

T2 - study protocol for a randomised phase III trial

AU - Janssen, J

AU - Staal, F H E

AU - Brouwer, C L

AU - Langendijk, J A

AU - de Jong, I J

AU - van Moorselaar, R J A

AU - Schuit, E

AU - Verzijlbergen, J F

AU - Smeenk, R J

AU - Aluwini, S

PY - 2022/5/2

Y1 - 2022/5/2

N2 - BACKGROUND: More than 60% of oligo-recurrent prostate cancer (PCa) patients treated with metastasis-directed radiotherapy (MDRT) develop biochemical recurrence within 2 years. This recurrence rate emphasises the need for improved treatment and patient selection. In line with the treatment of primary PCa, the efficacy of MDRT may be enhanced when combined with androgen-deprivation therapy (ADT). Furthermore, the availability of PSMA PET/CT offers an excellent tool for optimal patient selection for MDRT. This phase III randomised controlled trial will investigate the role of the addition of ADT to MDRT in oligo-recurrent PCa patients selected with PSMA PET/CT to enhance oncological outcome.METHODS: Two hundred and eighty patients will be randomised in a 1:1 ratio to the standard treatment arm (MDRT alone) or the experimental arm (MDRT + 6 months ADT). Patients with biochemical recurrence after primary treatment of PCa presenting with ≤ 4 metastases will be included. The primary endpoint is the 2.5-year metastases progression-free survival (MPFS). Secondary endpoints are acute and late toxicity, quality of life, biochemical progression-free survival, overall survival, and the sensitivity of the PSMA PET/CT for detecting oligometastases at low PSA-levels. So far, between March 2020 and December 2021, one hundred patients have been included.DISCUSSION: This phase III randomised controlled trial will assess the possible benefit of the addition of 6 months ADT to MDRT on metastases progression-free survival, toxicity, QoL and survival in PCa patients with 1-4 recurrent oligometastatic lesions.TRIAL REGISTRATION: ClinicalTrials.gov, NCT04302454 . Registered 10 March 2020.

AB - BACKGROUND: More than 60% of oligo-recurrent prostate cancer (PCa) patients treated with metastasis-directed radiotherapy (MDRT) develop biochemical recurrence within 2 years. This recurrence rate emphasises the need for improved treatment and patient selection. In line with the treatment of primary PCa, the efficacy of MDRT may be enhanced when combined with androgen-deprivation therapy (ADT). Furthermore, the availability of PSMA PET/CT offers an excellent tool for optimal patient selection for MDRT. This phase III randomised controlled trial will investigate the role of the addition of ADT to MDRT in oligo-recurrent PCa patients selected with PSMA PET/CT to enhance oncological outcome.METHODS: Two hundred and eighty patients will be randomised in a 1:1 ratio to the standard treatment arm (MDRT alone) or the experimental arm (MDRT + 6 months ADT). Patients with biochemical recurrence after primary treatment of PCa presenting with ≤ 4 metastases will be included. The primary endpoint is the 2.5-year metastases progression-free survival (MPFS). Secondary endpoints are acute and late toxicity, quality of life, biochemical progression-free survival, overall survival, and the sensitivity of the PSMA PET/CT for detecting oligometastases at low PSA-levels. So far, between March 2020 and December 2021, one hundred patients have been included.DISCUSSION: This phase III randomised controlled trial will assess the possible benefit of the addition of 6 months ADT to MDRT on metastases progression-free survival, toxicity, QoL and survival in PCa patients with 1-4 recurrent oligometastatic lesions.TRIAL REGISTRATION: ClinicalTrials.gov, NCT04302454 . Registered 10 March 2020.

KW - Androgen Antagonists/therapeutic use

KW - Androgens

KW - Chronic Disease

KW - Clinical Trials, Phase III as Topic

KW - Humans

KW - Male

KW - Neoplasm Recurrence, Local/drug therapy

KW - Positron Emission Tomography Computed Tomography

KW - Prostatic Neoplasms/drug therapy

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

U2 - 10.1186/s12885-022-09523-2

DO - 10.1186/s12885-022-09523-2

M3 - Article

C2 - 35501744

SN - 1471-2407

VL - 22

JO - BMC Cancer

JF - BMC Cancer

IS - 1

M1 - 482

ER -

Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial

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